Job Title: CQV Engineer

Job Description

Assisting in development, review, and approval of cGMP documents including, but not limited to: Master Validation Plans, FAT/SAT documents, Turnover Packages, SOP’s, specifications, traceability matrices, thermal mapping documents, and design documentation. Providing expertise and solutions to issues regarding CQV Lifecycle documentation in regards for applicable FDA/EMEA Regulations. Supporting validation activities for project activities including review of validation documentation (FAT, SAT, URS, SDS, IQ, OQ, PQ) and attendance at validation activities. Providing support to enforce CQV guidelines, policies and procedures for equipment, analytical equipment, utilities, and facilities (Examples: Bioreactor, Incubator Chromatography Systems, Harvest hold tank, Autoclave/Part washer, Vessel CIP and SIP, Chroma skid, TFF skid, etc.)

Hard Skills

• Authoring and Editing Validation Master Plans/documentation

• Biologic Process Equipment: Bioreactor, Incubator Chromatography Systems, Harvest hold tank, Autoclave/Part washer, Vessel CIP and SIP, Chroma skid, TFF skid, etc.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent

• Maintaining an inclusive environment through persistent self-reflection

• Building a culture of care, engagement, and recognition with clear outcomes

• Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.