Sr. Validation Engineer
3 weeks ago
Pay Rate: $60-70/hour depending on experience
Summary:We are looking for an exceptional individual to join as a temporary Senior Validation Engineer. This position will report directly to the Manager, Quality Engineering. This is an onsite role with an approximate duration of four months.
Responsibilities:
- Support the company’s Quality Engineering group with documentation and validation needs.
- Support validation activities and execution for expansion of new manufacturing workstations.
- Aid in department and document deviations.
- Perform validation activities as needed.
- Review and approval of validation documents.
- Provide knowledge to vendors and other contractors validation principles and correction plans/actions, as needed.
- Update Draft SOPs to the company’s templates
- With guidance from departmental subject matter expert / SOP owners, draft standard operation procedures and associated forms into required company SOP/Form formats.
- Utilize specified company document review / approval process to submit draft SOPs, Forms, and Protocols for approval.
- Assist in scheduling meetings within the organization and put together meeting minutes/notes, as needed.
- Establish schedules with vendors and internal departments as needed.
- Liaise between support organizations, Microbiology, Quality, Engineering, Validation, Regulatory Affairs, Process Development, etc.
- Provide weekly and monthly progress updates to project team.
- Attending Project meetings and relay project status as required.
- Writing / reviewing equipment and computer system documentation – specifications, C&Q test protocols, final reports, and routing for approval as required.
- Scheduling equipment and computer systems validation execution and documentation activities in accordance with project priorities.
- Escalate issues to leadership as needed.
- May perform project management and other tasks, as needed.
- Master's Degree and 2+ years' experience in Quality and/or Manufacturing within pharmaceutical, biotechnology, biologics, and/or cell therapy operations OR
- Bachelor’s Degree and 4+ years’ experience in Quality and/or Manufacturing within pharmaceutical, biotechnology, biologics, and/or cell therapy operations OR
- High School Degree and 8+ years' experience in Quality and/or Manufacturing within pharmaceutical, biotechnology, biologics, and/or cell therapy operations
- Knowledgeable in various areas of equipment and computerized systems with strong understanding of life cycle approach and change control management.
- Self-motivated / disciplined.
- Strong interpersonal communications skills with excellent technical writing abilities.
- Demonstrated application of engineering principles on projects.
- Possess in-depth knowledge of cGMP and regulations related to biotech / pharmaceutical qualifications.
- Proficient in Microsoft Office tools (Power point, MS Project, Excel, and Word).
- Able to work collaboratively and cross-functionally with other departments and vendors.
- Ensure a safe work environment is maintained through adherence to safety guidelines and policies set forth by the company
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