Sr. Validation Engineer

Syner-G • Bloomington, IN

1d • Remote

About The Position

We are seeking a Senior Validation Engineer with extensive experience supporting Fill-Finish operations, capping systems, lyophilization processes, and utilities within GMP-regulated environments. This role is part of a high-performing CQV team responsible for developing, executing, and turning over validation and qualification deliverables for complex manufacturing systems. Senior Validation Engineers are expected to operate with a high degree of independence and resourcefulness, proactively learning, troubleshooting, and driving activities forward with minimal supervision. The position requires strong engineering acumen, including the ability to review and interpret drawings to support CQV and process-related activities. Flexibility is essential, as responsibilities may shift quickly based on evolving project needs.

Requirements

• 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

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

Benefits

• 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.
• Employees also enjoy our generous flexible paid time off program, company-paid holidays, flexible working hours, and fully remote work options for most positions and the ability to work “almost anywhere.”
• However, if a physical work location is more for you, we have office locations in Greater Boston; San Diego, CA; Boulder, CO; and India.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 251-500 employees