Planet Pharma
Position Summary
The Validation Engineer will report to the VCGT Validation leadership or an appropriate designee to execute Commissioning, Qualification and Validation activities for the company\'s Cell and Gene Therapies Facility in one of their facilities located in South Boston and Cambridge. Key Responsibilities
Draft and implement Quality System documentation designed to establish good validation practices within the organization. Author URS, IQ, OQ and PQ protocols and execute them in compliance with GDP guidelines and internal quality standards. Support all stages of qualification of analytical instrument and manufacturing equipment. Support all stages of qualification of automated manufacturing equipment. Conduct Analytical Instrument Qualifications in accordance with USP and the company\'s SOPs. Conduct Automation Assessments to ensure compliance with 21 CFR Part 11. Coordinate with vendor personnel to schedule and execute test plans, if required. Coordinate with internal stakeholders to safely and effectively schedule CQV activities, whenever required. Effectively work with cross-departmental stakeholders, including but not limited to information services, EH&S, Global Security, design teams, and quality. Author documents related to or support process validation activities that include but are not limited to aseptic process simulations (APS), process performance qualification, material qualifications, etc. Develop cycles for sterilization processes and validate them, if required. Complete company assigned training and ensure compliance. Ensure that all Validation activities align with the current company SOPs, global standards and cGMP guidelines. Support right-the-first time culture for all documents distributed across the organization. Ensure the VCGT Validation team\'s reputation and partnership is flourishing with cross-functional teams. Ideal Candidates
Demonstrated ability to safely execute Validation activities in a dynamic fast-paced environment. Experience developing and executing Validation protocols in GMP Manufacturing and Analytical Laboratory environments. Receptive to change – adapts quickly to changing circumstances. Flexibility for off-shift hours, including weekend and night shift work. B.A., B.S. in Engineering or related discipline with 5-8 years of Validation experience or equivalent professional experience. Understanding and application of technical principles, theories, and concepts in the field, GMP, ISO, GAMP, ANSI. Pay ranges between $70-80/hr based on experience The Planet Group of Companies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
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The Validation Engineer will report to the VCGT Validation leadership or an appropriate designee to execute Commissioning, Qualification and Validation activities for the company\'s Cell and Gene Therapies Facility in one of their facilities located in South Boston and Cambridge. Key Responsibilities
Draft and implement Quality System documentation designed to establish good validation practices within the organization. Author URS, IQ, OQ and PQ protocols and execute them in compliance with GDP guidelines and internal quality standards. Support all stages of qualification of analytical instrument and manufacturing equipment. Support all stages of qualification of automated manufacturing equipment. Conduct Analytical Instrument Qualifications in accordance with USP and the company\'s SOPs. Conduct Automation Assessments to ensure compliance with 21 CFR Part 11. Coordinate with vendor personnel to schedule and execute test plans, if required. Coordinate with internal stakeholders to safely and effectively schedule CQV activities, whenever required. Effectively work with cross-departmental stakeholders, including but not limited to information services, EH&S, Global Security, design teams, and quality. Author documents related to or support process validation activities that include but are not limited to aseptic process simulations (APS), process performance qualification, material qualifications, etc. Develop cycles for sterilization processes and validate them, if required. Complete company assigned training and ensure compliance. Ensure that all Validation activities align with the current company SOPs, global standards and cGMP guidelines. Support right-the-first time culture for all documents distributed across the organization. Ensure the VCGT Validation team\'s reputation and partnership is flourishing with cross-functional teams. Ideal Candidates
Demonstrated ability to safely execute Validation activities in a dynamic fast-paced environment. Experience developing and executing Validation protocols in GMP Manufacturing and Analytical Laboratory environments. Receptive to change – adapts quickly to changing circumstances. Flexibility for off-shift hours, including weekend and night shift work. B.A., B.S. in Engineering or related discipline with 5-8 years of Validation experience or equivalent professional experience. Understanding and application of technical principles, theories, and concepts in the field, GMP, ISO, GAMP, ANSI. Pay ranges between $70-80/hr based on experience The Planet Group of Companies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
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