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pharma iq
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CountryHosted in United States
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Traffic rank#496,629 Site Rank
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Site age20 yrs old
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Site Owner informationWhois info
Website is Safe
Traffic rank
#496,629
#496,629
Site age
20 yrs
20 yrs
Location
United States
United States
Newest job postings for pharma iq
via Paylocity
schedule_type: Full-time
Description
Under general supervision, reviews processing equipment specification used in the development of Solid Oral, semi solid, liquid and Injectable dosage form products. Provides support in the areas of project coordination and follow through, assists with problem solving, efficiency studies and identification of process improvement opportunities. Involves developing manufacturing... processes for pharmaceutical products, creating and updating
Description
Under general supervision, reviews processing equipment specification used in the development of Solid Oral, semi solid, liquid and Injectable dosage form products. Provides support in the areas of project coordination and follow through, assists with problem solving, efficiency studies and identification of process improvement opportunities. Involves developing manufacturing... processes for pharmaceutical products, creating and updating procedures and specifications, writing reports on documentation studies performed and results obtained. Involvement in new product formulation, scale-up process optimization, process validation and technology transfers. Participates in the timely manufacture of supplies in support of clinical and stability programs.
JOB DUTIES & RESPONSIBILITIES
• Independently assists in formulation work in early stage research
• Oversees and coordinates development manufacturing events
• Operate general processing equipment/analytical instruments during formulation work, such as Granulator, Dryer, Blender, Tablet coater, Fluid Bed coating, HPLC, pH meter, viscometer, particle size testing etc. or any processing equipment as needed for the project.
• Perform IQ/OQ for all the equipment as needed
• Labels, transcribes and records documentation such as report sheets and laboratory notebooks as required by Standard Operating Procedures.
• Responsible for the design and development of products and process used in manufacturing from small-scale manufacturing to commercial operation.
• Analyzes and interprets protocol an experimental data to set product and process specifications.
• Analyzes existing equipment and recommends modifications when necessary for process optimization
• Presents test data and findings to management as required.
• Trains small scale- up manufacturing personnel as required
• Ability to lift up to 50 pounds.
Requirements
Minimum Education & Experience:
• Bachelor’s or Master’s degree in engineering or a related field from an accredited college or university.
• At least 2 or more years of experience in designing products/processes and installing operating and troubleshooting equipment in pharmaceutical manufacturing equipment (or food, or cosmetic manufacturing environment, or an equivalent combination of training and experience.
Required Knowledge & Skills:
• Current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA),
• Drug Enforcement Agency (DEA) and other regulatory requirements.
• Engineering principles applied to the manufacturing process including mixing, coating, die-cutting, pouching, and filling processes.v
• Pharmaceutical quality control and manufacturing processes.
• Techniques of sampling, testing and measuring, and principles of mathematical and statistical computations.
• Mechanical and electrical concepts.
• English usage, spelling, grammar and punctuation.
• Personal computer operations and Microsoft applications (CAD, Word, Access, and Excel).
• Statistical process control Show more details...
Under general supervision, reviews processing equipment specification used in the development of Solid Oral, semi solid, liquid and Injectable dosage form products. Provides support in the areas of project coordination and follow through, assists with problem solving, efficiency studies and identification of process improvement opportunities. Involves developing manufacturing... processes for pharmaceutical products, creating and updating procedures and specifications, writing reports on documentation studies performed and results obtained. Involvement in new product formulation, scale-up process optimization, process validation and technology transfers. Participates in the timely manufacture of supplies in support of clinical and stability programs.
JOB DUTIES & RESPONSIBILITIES
• Independently assists in formulation work in early stage research
• Oversees and coordinates development manufacturing events
• Operate general processing equipment/analytical instruments during formulation work, such as Granulator, Dryer, Blender, Tablet coater, Fluid Bed coating, HPLC, pH meter, viscometer, particle size testing etc. or any processing equipment as needed for the project.
• Perform IQ/OQ for all the equipment as needed
• Labels, transcribes and records documentation such as report sheets and laboratory notebooks as required by Standard Operating Procedures.
• Responsible for the design and development of products and process used in manufacturing from small-scale manufacturing to commercial operation.
• Analyzes and interprets protocol an experimental data to set product and process specifications.
• Analyzes existing equipment and recommends modifications when necessary for process optimization
• Presents test data and findings to management as required.
• Trains small scale- up manufacturing personnel as required
• Ability to lift up to 50 pounds.
Requirements
Minimum Education & Experience:
• Bachelor’s or Master’s degree in engineering or a related field from an accredited college or university.
• At least 2 or more years of experience in designing products/processes and installing operating and troubleshooting equipment in pharmaceutical manufacturing equipment (or food, or cosmetic manufacturing environment, or an equivalent combination of training and experience.
Required Knowledge & Skills:
• Current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA),
• Drug Enforcement Agency (DEA) and other regulatory requirements.
• Engineering principles applied to the manufacturing process including mixing, coating, die-cutting, pouching, and filling processes.v
• Pharmaceutical quality control and manufacturing processes.
• Techniques of sampling, testing and measuring, and principles of mathematical and statistical computations.
• Mechanical and electrical concepts.
• English usage, spelling, grammar and punctuation.
• Personal computer operations and Microsoft applications (CAD, Word, Access, and Excel).
• Statistical process control Show more details...
via ZipRecruiter
posted_at: 2 days agoschedule_type: Full-time
Overview:
TekWissen Group is a workforce management provider throughout the USA and many other countries worldwide. The job opportunity below is for one of our clients specializing in biotechnology product development services. Our client is dedicated to supplying laboratory equipment, chemicals, supplies, and services essential in healthcare, scientific research, safety, and education. As the... global leader in serving the field of science, our
Overview:
TekWissen Group is a workforce management provider throughout the USA and many other countries worldwide. The job opportunity below is for one of our clients specializing in biotechnology product development services. Our client is dedicated to supplying laboratory equipment, chemicals, supplies, and services essential in healthcare, scientific research, safety, and education. As the... global leader in serving the field of science, our client boasts an annual revenue of around $40 billion with a mission to empower customers to make the world healthier, cleaner, and safer. Our client's global team is committed to delivering an unparalleled blend of cutting-edge technologies, convenient procurement options, and pharmaceutical services under their industry-leading brands.
Position: Quality Engineer
Location: Chelmsford, MA - 01824
Duration: 6 Months
Job Type: Contract
Work Type: Onsite
Shift: Monday to Friday 08:00 AM to 05:00 PM
Job Summary:
• As a Quality Engineer, you will have the opportunity to support a life science manufacturing facility by acting as a Quality Engineering subject matter expert.
• You will make an impact by conducting root cause analysis (RCAs) and implementing corrective/preventative (CAPAs) actions to reach effective problem resolutions.
• You will also provide quality leadership to improve Critical to Quality (CTQ) parameters to support overall site improvement efforts.
Essential Functions:
• Investigate process/product deviations and out-of-specification conditions of our local factory and suppliers by applying various root cause analysis (RCA) methods and tools such as Cause and Effect Diagrams, 5-Whys etc.
• Ensure DEA compliance and act as a CSP coordinator
• Handle customer complaints with professionalism and efficacy.
• Troubleshoot electrodes and buffer solutions.
• Implement corrective and preventative actions (CAPAs) to prevent the recurrence of deviations and nonconformances.
• Verify the effectiveness of implemented changes utilizing the proper quality tools.
• Guide the disposition of non-conforming material (final product and raw material).
• Perform statistical analysis to monitor process and product performance and react to negative trends.
• Lead change controls for complex improvement projects utilizing risk-based methodologies.
• Have expert knowledge of Quality tools such as FMEA, risk analysis, validation principles, sampling plans, Six Sigma, and control plans.
• Lead and generate risk assessments (product and process- FMEAs).
• Have strong knowledge of process, product, and equipment validation principles (i.e. IQ/OQ/PQ..etc). This includes generating protocols and reports, creating acceptance criteria, establishing proper sampling plans and completing statistical analysis.
• Maintain the site's Quality Systems' conformance to ISO standards and regulatory requirements and policies.
• Drives for continuous improvements in all areas supports improvement efforts, implements changes, and verifies effectiveness of changes.
• Support internal and external audits, customer audits, and supplier audits.
• Perform Quality Assurance (QA) responsibilities as needed to support manufacturing activities and material release.
• Write or revise standard quality control operating procedures and quality system documentation as required.
• Write technical reports such as investigation summary reports and change management records.
Requirements Knowledge - Skills:
• Minimum: Bachelor of Science (BS) Degree in a scientific/Engineering discipline.
• Graduate degree (MS) is also a plus.
• A minimum of 6 years prior experience in a Quality Engineering role preferably in a cGMP Biotech or Life Science site.
• Proven experience with titrators and PH testing
• Strong verbal and written communication skills in English.
• Ability in technical and statistical writing.
• Must have experience in processes and procedures of ISO-9001: 2015 (ISO 13485 preferred) and DEA
• Ability to work in a matrix organization.
• A fundamental understanding of a quality system and its development, documentation, and implementation with respect to domestic and international standards or requirements.
• Understanding of the audit process including types of audits, planning, preparation, execution, reporting results, and follow-up.
• Strong analytical, problem-resolution, judgment, and decision-making skills
• Operation requires the use of safety equipment including but not limited to safety glasses and safety gloves.
• Demonstrated ability to conduct quality investigations including root cause analysis and determining corrective/preventative actions.
• Prior experience with the release and disposition of nonconforming products through the application of risk assessment and root cause analysis tools.
• Demonstrated validation proficiency, with knowledge of product, process, and equipment qualifications and validations (IQ/OQ/PQ).
• Good data analysis skills, with an ability to use statistical methods to conduct quality investigations.
• Lean Sigma Green or Black Belt certification is a plus.
• ASQ CQE is a plus.
• Excellent organization skills with strong attention to detail.
• Ability to multitask efficiently to support production demand.
• Computer skills: knowledge of Microsoft Office applications (Word, Excel, and PowerPoint) is a must.
TekWissen Group is an equal-opportunity employer supporting workforce diversity Show more details...
TekWissen Group is a workforce management provider throughout the USA and many other countries worldwide. The job opportunity below is for one of our clients specializing in biotechnology product development services. Our client is dedicated to supplying laboratory equipment, chemicals, supplies, and services essential in healthcare, scientific research, safety, and education. As the... global leader in serving the field of science, our client boasts an annual revenue of around $40 billion with a mission to empower customers to make the world healthier, cleaner, and safer. Our client's global team is committed to delivering an unparalleled blend of cutting-edge technologies, convenient procurement options, and pharmaceutical services under their industry-leading brands.
Position: Quality Engineer
Location: Chelmsford, MA - 01824
Duration: 6 Months
Job Type: Contract
Work Type: Onsite
Shift: Monday to Friday 08:00 AM to 05:00 PM
Job Summary:
• As a Quality Engineer, you will have the opportunity to support a life science manufacturing facility by acting as a Quality Engineering subject matter expert.
• You will make an impact by conducting root cause analysis (RCAs) and implementing corrective/preventative (CAPAs) actions to reach effective problem resolutions.
• You will also provide quality leadership to improve Critical to Quality (CTQ) parameters to support overall site improvement efforts.
Essential Functions:
• Investigate process/product deviations and out-of-specification conditions of our local factory and suppliers by applying various root cause analysis (RCA) methods and tools such as Cause and Effect Diagrams, 5-Whys etc.
• Ensure DEA compliance and act as a CSP coordinator
• Handle customer complaints with professionalism and efficacy.
• Troubleshoot electrodes and buffer solutions.
• Implement corrective and preventative actions (CAPAs) to prevent the recurrence of deviations and nonconformances.
• Verify the effectiveness of implemented changes utilizing the proper quality tools.
• Guide the disposition of non-conforming material (final product and raw material).
• Perform statistical analysis to monitor process and product performance and react to negative trends.
• Lead change controls for complex improvement projects utilizing risk-based methodologies.
• Have expert knowledge of Quality tools such as FMEA, risk analysis, validation principles, sampling plans, Six Sigma, and control plans.
• Lead and generate risk assessments (product and process- FMEAs).
• Have strong knowledge of process, product, and equipment validation principles (i.e. IQ/OQ/PQ..etc). This includes generating protocols and reports, creating acceptance criteria, establishing proper sampling plans and completing statistical analysis.
• Maintain the site's Quality Systems' conformance to ISO standards and regulatory requirements and policies.
• Drives for continuous improvements in all areas supports improvement efforts, implements changes, and verifies effectiveness of changes.
• Support internal and external audits, customer audits, and supplier audits.
• Perform Quality Assurance (QA) responsibilities as needed to support manufacturing activities and material release.
• Write or revise standard quality control operating procedures and quality system documentation as required.
• Write technical reports such as investigation summary reports and change management records.
Requirements Knowledge - Skills:
• Minimum: Bachelor of Science (BS) Degree in a scientific/Engineering discipline.
• Graduate degree (MS) is also a plus.
• A minimum of 6 years prior experience in a Quality Engineering role preferably in a cGMP Biotech or Life Science site.
• Proven experience with titrators and PH testing
• Strong verbal and written communication skills in English.
• Ability in technical and statistical writing.
• Must have experience in processes and procedures of ISO-9001: 2015 (ISO 13485 preferred) and DEA
• Ability to work in a matrix organization.
• A fundamental understanding of a quality system and its development, documentation, and implementation with respect to domestic and international standards or requirements.
• Understanding of the audit process including types of audits, planning, preparation, execution, reporting results, and follow-up.
• Strong analytical, problem-resolution, judgment, and decision-making skills
• Operation requires the use of safety equipment including but not limited to safety glasses and safety gloves.
• Demonstrated ability to conduct quality investigations including root cause analysis and determining corrective/preventative actions.
• Prior experience with the release and disposition of nonconforming products through the application of risk assessment and root cause analysis tools.
• Demonstrated validation proficiency, with knowledge of product, process, and equipment qualifications and validations (IQ/OQ/PQ).
• Good data analysis skills, with an ability to use statistical methods to conduct quality investigations.
• Lean Sigma Green or Black Belt certification is a plus.
• ASQ CQE is a plus.
• Excellent organization skills with strong attention to detail.
• Ability to multitask efficiently to support production demand.
• Computer skills: knowledge of Microsoft Office applications (Word, Excel, and PowerPoint) is a must.
TekWissen Group is an equal-opportunity employer supporting workforce diversity Show more details...
via Careers | Engineering Resource Group - TerkoTech
schedule_type: Full-timesalary: 90K–110K a year
Permanent position for a Validation Engineer for pharmaceutical manufacturing equipment and controls.
Primary responsibility is preparation of validation protocols (IQ/OQ) and commissioning documents for company equipment and control systems.
Work with company's control system programmers to develop and execute factory acceptance software test documents...
Work as an integral member of a project team.
Interface with the company equipment manufacturing
Permanent position for a Validation Engineer for pharmaceutical manufacturing equipment and controls.
Primary responsibility is preparation of validation protocols (IQ/OQ) and commissioning documents for company equipment and control systems.
Work with company's control system programmers to develop and execute factory acceptance software test documents...
Work as an integral member of a project team.
Interface with the company equipment manufacturing companies and internal departments to obtain the equipment, controls, and installation support documents necessary for protocol development.
Field execution and testing of approved validation protocols (IQ/OQ) and commissioning documents. This will include (but is not limited to) I/O forcing, alarm testing, sequence testing, PLC diagnostics, and PID loop performance testing.
Coordinate the efforts of the personnel involved during on-site qualification.
Specify, obtain, and maintain hardware and software necessary to perform in-house and on-site validation testing.
Prepare documents of field visits in a timely and professional manner, including field reports, daily labor logs, invoices, and expense reports.
Keep current with latest cGMP's, Validation technology and procedures, ISPE guidelines and related FDA publications.
Develop, maintain, and enhance positive interpersonal relationships with staff members. BS Engineering or Science
Minimum 5 years of related experience.
Must posses a valid driver's license.
Confined space entry training is required for potential entry into confined spaces within company supplied equipment.
Must have the ability to develop validation protocol (IQ and OQ), validation reports, and factory acceptance test documents. As such, good writing and grammar skills and attention to detail asre essential.
Experience is required in reading and interpreting electric and pneumatic controls, technical design documents, and PLC code.
Travel 25 to 35% to customer sites to perform validation testing of company equipment and control systems.
Familiarity with industry accepted practices for documenting test results, recording of deviations, and deviation resolutions.
Must have excellent communication skills and be comfortable presenting the validation results to our customer's project team (QA, validation, project management, etc.).
Must have good troubleshooting skills. Prior experience in control system programming, commissioning, calibration, I/O forcing, PID loop tuning, and/or equipment service is desirable.
Must be willing and be capable to climb ladders and to enter restrictive spaces.
Must have an understanding of computer system validation including knowledge of GAMP 5 and CFR 21 Part Show more details...
Primary responsibility is preparation of validation protocols (IQ/OQ) and commissioning documents for company equipment and control systems.
Work with company's control system programmers to develop and execute factory acceptance software test documents...
Work as an integral member of a project team.
Interface with the company equipment manufacturing companies and internal departments to obtain the equipment, controls, and installation support documents necessary for protocol development.
Field execution and testing of approved validation protocols (IQ/OQ) and commissioning documents. This will include (but is not limited to) I/O forcing, alarm testing, sequence testing, PLC diagnostics, and PID loop performance testing.
Coordinate the efforts of the personnel involved during on-site qualification.
Specify, obtain, and maintain hardware and software necessary to perform in-house and on-site validation testing.
Prepare documents of field visits in a timely and professional manner, including field reports, daily labor logs, invoices, and expense reports.
Keep current with latest cGMP's, Validation technology and procedures, ISPE guidelines and related FDA publications.
Develop, maintain, and enhance positive interpersonal relationships with staff members. BS Engineering or Science
Minimum 5 years of related experience.
Must posses a valid driver's license.
Confined space entry training is required for potential entry into confined spaces within company supplied equipment.
Must have the ability to develop validation protocol (IQ and OQ), validation reports, and factory acceptance test documents. As such, good writing and grammar skills and attention to detail asre essential.
Experience is required in reading and interpreting electric and pneumatic controls, technical design documents, and PLC code.
Travel 25 to 35% to customer sites to perform validation testing of company equipment and control systems.
Familiarity with industry accepted practices for documenting test results, recording of deviations, and deviation resolutions.
Must have excellent communication skills and be comfortable presenting the validation results to our customer's project team (QA, validation, project management, etc.).
Must have good troubleshooting skills. Prior experience in control system programming, commissioning, calibration, I/O forcing, PID loop tuning, and/or equipment service is desirable.
Must be willing and be capable to climb ladders and to enter restrictive spaces.
Must have an understanding of computer system validation including knowledge of GAMP 5 and CFR 21 Part Show more details...
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