Syner-G · 17 hours ago
Sr. Validation Engineer
Pittsburgh, PA
Full-time
Hybrid
Senior Level
7+ years expSyner-G is a company dedicated to enhancing the quality of life through breakthrough science and therapies. They are seeking a Sr. Validation Engineer to lead validation activities in GMP-regulated environments, managing validation scope and providing guidance to junior team members.
Health CareManufacturingPharmaceutical
No H1B
Responsibilities
Lead the generation and execution of validation lifecycle documentation (FAT, SAT, IOQ, PQ) for equipment, utilities, facilities, cleaning processes, shipping systems, and other GMP‑regulated assets
Oversee 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, validation master plans, execution plans, URS, FRS, design specifications, FAT documentation, verification protocols, and commissioning test procedures
Prepare comprehensive 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
Lead P&ID walkdowns to verify installation, configuration, and system readiness
Perform and oversee thermal mapping of temperature‑controlled chambers, warehouses, and SIP processes
Support resolution of regulatory observations, audit findings, and manufacturing site issues related to validation
Lead periodic reviews and requalification activities for temperature‑controlled systems and other validated assets
Provide technical mentorship and guidance to junior validation staff
Collaborate cross‑functionally to ensure validation activities align with project timelines and operational needs
Qualification
Required
Bachelor's degree in a life science, engineering, or related technical field
7–11 years of experience in the biotech, pharmaceutical, or medical device industry
Strong knowledge of FDA cGMP requirements, FMEA, and risk‑based validation principles
Advanced validation expertise in equipment, computerized systems (CSV), analytical methods, and process validation
Extensive experience generating protocols for automated production systems, with emphasis on computerized equipment and systems validation
Demonstrated experience writing and reviewing IQ, OQ, PQ, and CSV reports
Experience supporting audits, regulatory inspections, and remediation activities
Strong verbal and written communication skills, with the ability to explain complex technical concepts to diverse audiences
Highly organized with strong documentation and analytical skills
Ability to lead validation workstreams, manage multiple priorities, and work independently
Strong problem‑solving skills and experience supporting investigations and root‑cause analysis
Ability to mentor junior engineers and contribute to team development
Benefits
Market competitive base salary and annual incentive plan
Robust benefit offerings
Generous flexible paid time off program
Company-paid holidays
Flexible working hours
Fully remote work options for most positions
Company
Syner-G
Syner-G is a Strategic Development & Delivery Partner™ to biopharma innovators.
201-500 employees
Funding
Current Stage
Growth StageLeadership Team
Ron Kraus
Chief Executive Officer
Prabu Nambiar
Founder, Board Member
Recent News
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