Validation Engineer

About the role

We are seeking a Validation Engineer with 4–7 years of experience to support the development, execution, and management of validation activities across equipment, utilities, facilities, computerized systems, and manufacturing processes.

Responsibilities

• Generate and execute validation lifecycle documentation (FAT, SAT, IOQ, PQ) for equipment, utilities, facilities, cleaning processes, shipping systems, and other GMP-regulated assets.
• Support validation activities for internal and client tech transfer projects, including authoring, executing, reviewing, and closing validation documents such as risk assessments, validation plans, IQ, OQ, PQ, test methods, and validation reports.
• Write, review, and revise qualification and verification documents, including SOPs, master validation plans, execution plans, URS, FRS, design specifications, FAT documentation, verification protocols, and commissioning test procedures.
• Prepare summary reports for validation, verification, commissioning, and requalification activities.
• Develop and support procedures, investigations, protocols, reports, and change controls for Maintenance, Engineering, and Quality functions.
• Perform P&ID walkdowns to verify installation and system readiness.
• Support resolution of regulatory observations, audit findings, and manufacturing site issues related to validation.
• Conduct thermal mapping of temperature-controlled chambers, warehouses, and SIP processes.
• Perform periodic reviews and requalification activities for temperature-controlled systems and other validated assets.

Qualifications and Requirements

• Education: Bachelor’s degree in a life science, engineering, or related technical field.
• Technical Experience: 4–7 years of experience in the biotech, pharmaceutical, or medical device industry.
• Knowledge, Skills, and Abilities: Strong verbal and written communication skills, detail-oriented with strong organizational and documentation skills, ability to work independently and collaboratively in a fast-paced, regulated environment, strong problem-solving skills and the ability to support investigations and root-cause analysis.

Total Rewards Program

We define total rewards as compensation, benefits, remote work/flexibility, development, recognition, and our culture with programs that support each of our reward pillars. This includes a market competitive base salary and annual incentive plan, robust benefit offerings, and ongoing recognition and career development opportunities.

Legal Statement

Syner-G is proud to be an Equal Employment Opportunity and Affirmative Action employer. All employment decisions, including the recruiting, hiring, placement, training availability, promotion, compensation, evaluation, disciplinary actions, and termination of employment (if necessary) are made without regard to the employee’s race, color, creed, religion, sex, pregnancy or childbirth, personal appearance, family responsibilities, sexual orientation or preference, gender identity, political affiliation, source of income, place of residence, national or ethnic origin, ancestry, age, marital status, military veteran status, unfavorable discharge from military service, physical or mental disability, or on any other basis prohibited by applicable law. Syner-G is an E-Verify employer.