Remote CQV Project Engineer – Biopharma GMP

Syner-G BioPharma Group

Gaithersburg (MD)

On-site

USD 110,000 - 150,000

Full time

36 hours ago

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Benefits offered by this job

Market-competitive base salary

Annual incentive plan

Robust benefits

Career development opportunities

Generous PTO

Job summary

Syner-G BioPharma Group is seeking experienced Project Engineers to support IQ QCV activities in GMP biopharma manufacturing environments. You will develop and execute IQ protocols for bioreactors, media tanks, and utilities, ensuring installation aligns with P&IDs and engineering specs.

Your role includes field walkdowns, document reviews, and collaboration with Engineering, Manufacturing, QA, Validation, and vendors to ensure turnaround readiness and regulatory readiness.

Qualifications

3+ years of CQV/Validation/Engineering experience in GMP environments.
Experience developing/executing IQ protocols for process equipment.
Familiarity with GMP documentation, GDP, and regulatory requirements.

Responsibilities

Develop, review, and execute IQ protocols for bioreactors and process equipment.
Verify installation against P&IDs and vendor data.
Perform field walkdowns and inspections to ensure compliance.
Review turnover packages, certifications, and manuals.
Identify and resolve qualification discrepancies and deviations.
Support system turnover and qualification readiness with cross-functional teams.

Skills

CQV methodologies

Equipment qualification

GMP/GDP knowledge

Technical writing

Education

Bachelor's Degree in Engineering or Life Sciences

Tools

Kneat

Job description

Your role includes field walkdowns, document reviews, and collaboration with Engineering, Manufacturing, QA, Validation, and vendors to ensure turnaround readiness and regulatory readiness.

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