Equipment Validation Specialist, Level III (Biopharma)

Location: On-site in Portsmouth, New Hampshire, United States. Relocation assistance is available for eligible candidates and their families.

Company

hirify.global operates biopharmaceutical manufacturing sites across five continents and develops solutions that help turn breakthrough ideas into viable therapies.

What you will do

• Perform validation maintenance quality systems reviews and re-qualification activities to keep GMP equipment in a validated state.
• Schedule personal activities and coordinate tasks for Level I and Level II Specialists.
• Assess change controls and support validation activities for GMP equipment.
• Develop validation protocols from validation plans and engineering documentation.
• Review and approve SOPs, protocols, change controls, and deviations using strong technical expertise.
• Manage validation equipment and supplies, train personnel, and perform activities in DMS, LIMS, and TrackWise.

Requirements

• Bachelor’s degree preferred, or equivalent industry experience.
• At least 2 years of experience with manufacturing processes, quality control, or environmental monitoring.
• Strong technical writing skills and meticulous, accurate documentation practices.
• Ability to write discrepancies, perform root cause analysis, and conduct quality risk assessments.
• Experience with DMS, LIMS, and TrackWise change control systems.
• Ability to work independently on-site in Portsmouth, New Hampshire.

Culture & Benefits

• Collaborative and inclusive work environment.
• Career growth, professional development, mentoring, and supportive leadership.
• Access to advanced technologies and tools.
• Competitive compensation and benefits package with 401(k) matching.
• Commitment to ethical and sustainable practices.