Syner-G · 13 hours ago
Validation Engineer
Pittsburgh, Pennsylvania, United States
Full-time
Onsite
Mid, Senior Level
4+ years expSyner-G is a company focused on enhancing the quality of life through innovative biopharma solutions. They are seeking a Validation Engineer to support validation activities across various systems and processes, ensuring compliance with quality standards and regulatory requirements. The role involves generating and executing validation documentation and supporting operational readiness and continuous improvement initiatives.
Health CareManufacturingPharmaceutical
No H1B
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
Conduct thermal mapping of temperature‑controlled chambers, warehouses, and SIP processes
Support resolution of regulatory observations, audit findings, and manufacturing site issues related to validation
Perform periodic reviews and requalification activities for temperature‑controlled systems and other validated assets
Qualification
Required
Bachelor's degree in a life science, engineering, or related technical field
4–7 years of experience in the biotech, pharmaceutical, or medical device industry
Strong knowledge of FDA cGMP requirements, FMEA, and risk‑based validation principles
Hands‑on validation experience in equipment, computerized systems (CSV), analytical methods, and process validation
Experience generating protocols for automated production systems, with emphasis on computerized equipment and systems validation
Demonstrated experience writing IQ, OQ, PQ, and CSV reports
Experience with executing validation scope for CTUs, Lab Equipment, misc. equipment
Strong verbal and written communication skills, with the ability to explain technical concepts to non‑technical stakeholders
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
Benefits
Market competitive base salary
Annual incentive plan
Robust benefit offerings
Ongoing recognition and career development opportunities
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
Company data provided by crunchbase