Senior Validation Engineer (Pharmaceutical)

Location: On premise in Rochester, Michigan, United States. Candidates must have permanent authorization to work in the U.S. by any employer. U.S. work visa sponsorship is not available.

Annual base salary: $82,700–$137,900, plus eligibility for a 10% performance bonus.

Company

hirify.global develops and manufactures pharmaceutical products with a focus on quality, compliance, and patient safety.

What you will do

• Plan, schedule, execute, and lead qualification, validation, and requalification activities for manufacturing processes, equipment, facilities, utilities, products, cleaning, sterilization, and laboratory systems.
• Author validation lifecycle documents, including project plans, master plans, SOPs, requirements, protocols, test scripts, reports, and periodic requalification documentation.
• Coordinate with area owners, suppliers, and cross-functional departments to complete validation requirements and maintain compliance with policies, regulations, and guidelines.
• Investigate deviations, support corrective actions, perform gap and risk assessments, and review change controls to protect the validated state.
• Support regulatory inspections, audits, technical training, APQR preparation, and validation responsibility reviews.
• Perform process capability analysis and lead projects that reduce process risk and improve plant and process productivity.

Requirements

• High school diploma with 8+ years of relevant experience, associate’s degree with 6+ years, BA/BS with 2+ years, or MBA/MS with relevant experience.
• Proven expertise in Good Manufacturing Practices and strong knowledge of quality systems and processes.
• Familiarity with document management, enterprise application, and quality tracking systems.
• Strong verbal and written communication skills and the ability to work independently and collaboratively.
• Ability to lift at least 30 pounds, bend, stand for extended periods, use ladders, and work in controlled environments.
• Must not have a penicillin allergy and must complete aseptic gowning and cleanroom technique qualification.

Nice to have

• Technical experience validating pharmaceutical processes, equipment, utilities, facilities, or computer systems.
• Experience with sterile products, medical devices, regulatory audits, and compliance.
• Strong analytical, problem-solving, organizational, mentoring, and time-management skills.
• Experience using generative AI tools such as ChatGPT or Microsoft Copilot responsibly.

Culture & Benefits

• Full-time employment in a quality-focused, science-based, and risk-based compliance environment.
• Comprehensive medical, prescription drug, dental, and vision coverage.
• 401(k) matching, additional retirement contributions, paid vacation, holidays, and personal days.
• Paid caregiver, parental, and medical leave.
• Minimal travel for training or seminars; occasional after-hours and weekend support may be required.
• Relocation assistance may be available based on business needs and eligibility.

Hiring process

• Applications are accepted until October 1, 2026.
• Employment eligibility and permanent U.S. work authorization will be verified.