Sr. Validation Engineer

POSITION OVERVIEW:

We are seeking a Sr. Validation Engineer with 7–11 years of experience to lead validation activities across equipment, utilities, facilities, computerized systems, and manufacturing processes within GMP-regulated environments. This role is responsible for developing, executing, and managing validation lifecycle documentation while ensuring compliance with regulatory expectations and internal quality standards. The Sr. Validation Engineer will serve as a subject matter expert, support complex technical projects, and provide guidance to junior team members.

KEY RESPONSIBILITIES:

• Lead validation lifecycle documentation for GMP-regulated assets.
• Oversee validation activities for tech transfer projects, including risk assessments, validation plans, IQ, OQ, PQ, test methods, and reports.
• Write and review qualification, verification, SOP, validation master plan, execution plan, URS, FRS, design specification, FAT, and commissioning documents.
• Prepare summary reports for validation, verification, commissioning, and requalification.
• Support procedures, investigations, protocols, reports, and change controls.
• Lead P&ID walkdowns.
• Perform and oversee thermal mapping.
• Support regulatory observations, audit findings, and manufacturing site issues.
• Lead periodic reviews and requalification activities.
• Mentor junior validation staff.
• Collaborate cross-functionally on project timelines and operational needs.

QUALIFICATIONS AND REQUIREMENTS:

• Bachelor’s degree in life science, engineering, or a 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, analytical methods, and process validation.
• Experience generating protocols for automated production systems and writing and reviewing IQ, OQ, PQ, and CSV reports.
• Experience supporting audits, regulatory inspections, and remediation activities.
• Strong communication, documentation, analytical, organizational, problem-solving, and root-cause analysis skills.
• Ability to lead workstreams, manage priorities, work independently, and mentor junior engineers.

ESSENTIAL FUNCTIONS:

The role requires computer use, reaching, talking, listening, walking, sitting, and occasionally standing, stooping, or kneeling. The employee may lift and carry objects weighing up to 25 pounds. The work environment is indoors, temperate, and typical of an office environment.

TOTAL REWARDS PROGRAM:

The total rewards program includes competitive base salary, annual incentives, benefits, flexible paid time off, company-paid holidays, flexible working hours, remote work options, development opportunities, recognition, and fully remote work options for most positions. Syner-G cannot sponsor or take over sponsorship of an employment visa at this time.