We at Eliquent are looking for an experienced Validation Engineer to immediately join our Eliquent Mid Atlantic Team onsite in Marietta, PA.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Commissioning, Qualification, and Validation of formulation isolators, wash isolators, downflow booths, and CIP Skids.
- Delivery of Validation Life cycle deliverables, such as:
- Drafting, review, and approval of equipment risk assessments, User Requirement Specifications, Design Qualification, and equipment Validation Plans.
- Drafting, review, approval, and execution of SAT/IQ/OQ/PQ protocols and reports.
- Assist on system implementation tasks, as required.
- Assist on resolution of any system qualification deviations
- Attend periodic meetings and provide updates
QUALIFICATIONS AND REQUIREMENTS:
- Bachelors Degree in engineering, science, or similar field or equivalent experience
- 5-10 years experience in validation services in a regulated, manufacturing environment within the biotechnology, pharmaceutical, or medical device industry
- Experience in executing protocols including systems such as Process Validation, utilities, manufacturing equipment and basic knowledge of laboratory validation
- Working knowledge of FDA and cGMP regulations and documentation practice
- Ability to read and interpret Piping and Instrument Diagrams (P&IDs), and electrical diagrams
What We Offer:- Competitive Compensation: Attractive salary and comprehensive benefits package for full-time and part-time employees, including health, dental, vision, and life insurance, a 401(k) plan with employer match, a generous paid time off policy, and additional perks. Compensation is commensurate with professional experience.
- Career Development: Opportunities for professional growth and advancement within a supportive and innovative environment.
- Work-Life Balance: Flexible work arrangements and a commitment to maintaining a healthy work-life balance.
