Syner-G · 3 hours ago
Sr. Validation Engineer
Bloomington, IN
Full-time
Onsite
Senior Level
7+ years expSyner-G is a company focused on enhancing the quality of life through their expertise in biopharma product development. They are seeking a Senior Validation Engineer to support Fill-Finish operations and develop validation deliverables for manufacturing systems within GMP-regulated environments.
Health CareManufacturingPharmaceutical
No H1B
Responsibilities
Develop and execute CQV lifecycle documentation including FAT, SAT, IOQ, and PQ for Fill-Finish equipment, capping systems, lyophilizers, utilities, and supporting process systems
Generate, execute, and close validation lifecycle documents including RA, VP, IQ, OQ, PQ, TM, and VR
Lead protocol development, execution, deviation resolution, and final turnover packages
Perform P&ID walkdowns and verify field installation against design documentation
Support thermal mapping activities for temperature-controlled chambers, warehouses, and SIP processes
Review and interpret engineering drawings, specifications, and vendor documentation to support CQV activities
Provide technical input during equipment startup, troubleshooting, and issue resolution
Support process and equipment readiness for tech transfer and manufacturing operations
Assist in resolving regulatory observations or site issues related to validation or CQV
Write, review, and revise qualification and validation documents including SOPs, master plans, URS, FRS, design specifications, FAT documents, and commissioning test procedures
Prepare summary reports for validation, verification, commissioning, and requalification activities
Support change controls, investigations, and engineering documentation updates
Execute periodic reviews and requalification activities for temperature-controlled systems
Partner with Manufacturing, Engineering, Quality, Facilities, and Automation teams to ensure alignment and timely execution of CQV deliverables
Coordinate with vendors and contractors to support equipment qualification and turnover
Operate as a senior technical resource, providing guidance to junior team members as needed
Qualification
Required
Bachelor's degree in Engineering, Life Sciences, or a related technical field
7–11 years of experience in biotech, pharmaceutical, or regulated manufacturing environments
Strong validation expertise in Fill-Finish, capping, lyophilization, and utilities systems
Experience supporting CQV activities including protocol development, execution, and turnover
Knowledge of FDA cGMPs, FMEA, risk analysis, and validation lifecycle principles
Experience with automated production systems and computerized equipment validation
Demonstrated ability to write IQ, OQ, PQ, and CSV documentation and reports
Strong engineering mindset with the ability to interpret drawings and technical documentation
Excellent verbal and written communication skills
Ability to work independently with minimal supervision in fast-paced project environments
Strong problem-solving skills and the ability to adapt quickly to changing priorities
Ability to collaborate effectively with cross-functional teams and external partners
Benefits
Market competitive base salary
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
The ability to work 'almost anywhere'
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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