Validation / Calibration

Sr. Process Validation Engineer Direct Hire MA

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Job ID: 15320 Direct Hire MA

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Our client is a highly-regarded, global biopharmaceutical company in the greater Boston area looking to hire an experienced Process Validation engineer to support diverse biologic manufacturing, including developing and executing process validation protocols and studies. You will also provide technical support for new product introductions (PPQ campaigns), continuous life-cycle management, and defend processes against regulatory agencies. Previous experience authoring process validation protocols is a huge plus!

Responsibilities include but are not limited to;
•  Develop quality system elements for process validation related activities such as risk assessments, CAPAs, cGMP investigations, and change controls.
•  Contribute to the design and development of a robust validation strategy
•  Represent process validation for tech transfers and identify continuous improvement opportunities for Stage 3

Formal descriptions can be supplied for interested candidates. 

Qualified candidates will have a BS or MS in an Engineering, Life Science, or related field with a minimum of 3-10 years of biopharmaceutical production experience including extensive knowledge of cGMP guidelines, process validation, and relevant international regulatory requirements. Must also have demonstrated experience with performing risk assessments, troubleshooting unit operations, and analyzing data.

Must be authorized to work in the US indefinitely to be considered.

All resumes will be kept strictly confidential until you choose to pursue a specific opportunity with one of our clients.

Process Validation Manager Direct Hire MA

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Job ID: 15219 Direct Hire MA

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Our client is a major global biopharma company in the greater Boston area looking to hire an experienced Process Validation Manager to directly support PPQ success for various biologics. You will provide expertise to technical teams in the implementation of strategies for process validation protocols and studies, including Validation Master Plans. This leadership opportunity leads PPQ at the site level and will manage a team of 4-5 direct reports.

Responsibilities include but are not limited to;
•  Lead PPQ team, develop direct reports, and ensure production targets are met in compliance with cGMP and corporate policies
•  Spearhead the process validation function for the site and drive continuous improvement and harmonization across the organization, developing KPIs and monitoring execution performance
•  Author protocols and reports for process validation activities 

Formal descriptions can be supplied for interested candidates. 

Qualified candidates will have a BS or MS in an Engineering, Life Science or related field and a minimum of 10+ years of biopharmaceutical production experience including extensive knowledge of cGMP guidelines, ICH/FDA, and other international regulatory requirements relevant for process validation. Must also have direct experience with PPQ support and execution of process validation studies. Minimum 3 years of people management required.

Must be authorized to work in the US indefinitely to be considered.

All resumes will be kept strictly confidential until you choose to pursue a specific opportunity with one of our clients.