Validation Engineer

Validation Engineer

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Company Description
At Syner-G, we enable our people to build careers that impact positively on their quality of life. Through our expertise, insight, consulting, and management skills, we accelerate breakthrough science and delivery of life‑enhancing therapies to more patients. We work across a diverse range of clients and projects, supporting many organizations from the most critical phases of the drug discovery and approval process through to commercialization.

Position Overview
We are seeking a Validation Engineer to assist with the development and execution of validation for various types of processes. The Validation Engineer will be responsible for driving overall quality performance and compliance throughout the organization by defining, implementing, and maintaining the validation program.

Key Responsibilities

• Generate and execute life cycle documentation (FAT, SAT, IOQ, PQ) for cleaning, shipping, facilities, utilities, systems, equipment, and processes for (re) qualification/(re) verification.
• Support validation activities for Basecamp and client Tech Transfer projects, including generation, execution, review, and closure of validation life cycle documents (RA, VP, IQ, OQ, PQ, TM, VR).
• Write, review, and revise a variety of Installation, Operation, and Performance qualification/verification related documents, including SOPs, validation/verification master plans, guidelines and execution plans, automation, engineering design, commissioning, qualification or other technical documents, URS, FRS, detailed design specifications, FAT, verification protocols, and/or commissioning test procedures.
• Write reports to summarize validation/verification/commissioning and/or revalidation/verification/commissioning activities.
• Write procedures, investigations, protocols, reports, change controls, etc., to support the Maintenance and Engineering departments.
• Perform P&. Perform thermal mapping of temperature‑controlled chambers, warehouses, and SIP processes.
• Support the resolution of regulatory observations or manufacturing site issues.
• Execute periodic reviews and requalification for temperature chambers.

Qualifications and Requirements

• Bachelor’s degree in a related life science field.
• 4-7 years of experience within the biotech, pharmaceutical, or medical device industry.
• Knowledge and experience working with FDA cGMP, FMEA, and Risk Analysis.
• Validation expertise in Equipment, CSV, Method, and Process.
• Protocol generation experience of automated production systems, with a concentration on computerized equipment and systems validation.
• Report writing experience for IQ, OQ, PQ, and CSV.

Compensation
The expected salary range for this position is $88,000 to $104,000. Actual pay will be determined based on experience, qualifications, geographic location, and other job‑related factors permitted by law.

Legal Statement
Syner‑G is proud to be an Equal Employment Opportunity and affirmative action employer. All employment decisions are made without regard to race, color, creed, religion, sex, pregnancy, sexual orientation, gender identity, or any other basis prohibited by law.

Applicants must have current work authorization when accepting a position at Syner‑G. Currently, Syner‑G is unable to sponsor or take over sponsorship of an employment visa at this time.