Senior CQV Engineer

ELIQUENT Life Sciences; Marietta (PA); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Health insurance

401(k) plan with employer match

Paid time off

Job summary

ELIQUENT Life Sciences is seeking an experienced Validation Engineer to join our Mid Atlantic Team onsite in Marietta, PA. You will lead commissioning, qualification and validation activities for isolation systems and CIP skids, developing and executing IQ/OQ/PQ protocols and related reports.

The role requires 5–10 years in regulated manufacturing, familiarity with FDA/cGMP, and ability to read P&IDs and diagrams.

Qualifications

• Bachelor's 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 P&IDs, and electrical diagrams

Responsibilities

• Commissioning, qualification, and validation of isolators, downflow booths, and CIP skids.
• Deliver validation life cycle deliverables: risk assessments, URS, DQ, and equipment validation plans.
• Draft, review, approve, and execute IQ/OQ/PQ protocols and reports.
• Assist on system implementation tasks as required.
• Assist on resolution of system qualification deviations.
• Attend periodic meetings and provide updates

Skills

Validation expertise

Regulatory compliance

P&ID reading

Documentation practices

Education

Bachelor’s degree in engineering or science

Tools

Process validation protocols

Job description

ELIQUENT Life Sciences is the leading global consulting firm providing solutions to life science companies researching, developing, and manufacturing innovative products to serve patients and respond to public health challenges around the world. ELIQUENT is committed to serving clients’ needs with extensive expertise, unwavering integrity, and strategic insight in a manner that supports availability of safe, effective, and high-quality drugs, biologics, and medical devices. For more information, please visit our website at www.eliquent.com.

We at Eliquent are looking for an experienced Validation Engineer to immediately join our 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.