Validation Engineer

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Validation Engineer – Contract – Seattle, WA – $61.00-$71.00/hr.

The final salary or hourly wage, as applicable, paid to each candidate/applicant for this position is ultimately dependent on a variety of factors, including, but not limited to, the candidate’s/applicant’s qualifications, skills, and level of experience as well as the geographical location of the position.

The end client is unable to sponsor or transfer visas for this position; all parties authorized to work in the US without sponsorship are encouraged to apply.

A Pharmaceutical Company is seeking a Validation Engineer in Seattle, WA.

Role Description

Reporting to the Vector Process Validation Lead within Global Manufacturing Science and Technology, this role will define and implement the process validation strategy and studies for our lentiviral vector products. This role will be responsible for the development of process validation master plans, process validation study design, protocols, and reports and implementation at both internal and external manufacturing sites. The role will provide technical oversight for initial process performance qualification (PPQ) as well as throughout the product life cycle. Candidate will interface with the Site MSAT and other cross-functional groups to ensure the process validation strategy is appropriate. The candidate will also contribute to process validation-related investigations, troubleshooting efforts, and responses to emerging requirements or questions during health authority interactions. Candidate will participate in the development of process characterization and process control strategies as needed to ensure that the control strategies are consistent with the process validation standards and manufacturing requirements.

• Sound scientific understanding of process validation principles
• Good understanding of the global health authority expectations around process validation
• Understanding of GMP concepts and quality systems necessary to ensure sound process validation framework
• Good understanding of equipment/system design and validation
• Excellent communication skills, both oral and written
• Experience with development of Process Validation Master Plans, Process Validation Protocols, and Process Validation Reports

Skills & Requirements

• Required Bachelor’s Degree in Life Sciences or Chemical Engineering
• Minimum 5 years of experience in pharma/biotech industry, min 2 years of validation experience in a GMP environment
• Preference will be given to candidates with Cell Therapy experience
• Develop and implement validation policies to define robust process validation program within the cell therapy product lifecycle.
• Participate in generation and approval of PPQ enabling deliverables generated during late stage process development and characterization.
• Define process validation strategy for upcoming products and support PPQ execution in a multi-site commercial environment.
• Author CMC content for regulatory filings.
• Represent validation on contract manufacturing projects, including vendor selection, process transfer and process validation. Direct responsibility for validation activities at contract manufacturing organizations, including validation gaps assessments during CMO selection and tech transfers
• Provide oversight via review and approval, as appropriate, of site level deliverables, including Validation Master Plans, process validation protocols and risk assessments.
• Develop and implement continuous process monitoring strategies and ensure process validation status throughout commercial lifecycle
• Respond to site independent process validation troubleshooting issues, questions
• Coordinate responses to health authority questions on process validation.
• Work with process, analytical development and MSAT groups to review, approve the development of process characterization and process control strategies as needed to ensure that the control strategies are consistent with the process validation standards and manufacturing requirements.
• Author, review and approve, as needed, various validation documents including, but not limited to, protocols, PPQ plans, final reports and process validation master plans

Benefits/Other Compensation

This position is a contract/temporary role where Hays offers you the opportunity to enroll in full medical benefits, dental benefits, vision benefits, 401K and Life Insurance ($20,000 benefit).

Why Hays?

You will be working with a professional recruiter who has intimate knowledge of the industry and market trends. Your Hays recruiter will lead you through a thorough screening process in order to understand your skills, experience, needs, and drivers. You will also get support on resume writing, interview tips, and career planning, so when there’s a position you really want, you’re fully prepared to get it.

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Hays is committed to building a thriving culture of diversity that embraces people with different backgrounds, perspectives, and experiences. We believe that the more inclusive we are, the better we serve our candidates, clients, and employees. We are an equal employment opportunity employer, and we comply with all applicable laws prohibiting discrimination based on race, color, creed, sex (including pregnancy, sexual orientation, or gender identity), age, national origin or ancestry, physical or mental disability, veteran status, marital status, genetic information, HIV-positive status, as well as any other characteristic protected by federal, state, or local law. One of Hays’ guiding principles is ‘do the right thing’. We also believe that actions speak louder than words. In that regard, we train our staff on ensuring inclusivity throughout the entire recruitment process and counsel our clients on these principles. If you have any questions about Hays or any of our processes, please contact us.

In accordance with applicable federal, state, and local law protecting qualified individuals with known disabilities, Hays will attempt to reasonably accommodate those individuals unless doing so would create an undue hardship on the company. Any qualified applicant or consultant with a disability who requires an accommodation in order to perform the essential functions of the job should call or text 813.336.5570.

Drug testing may be required; please contact a recruiter for more information. #1149736