Validation Specialist – Pharmaceutical Manufacturing
Are you an experienced validation professional looking to make an impact in pharmaceutical manufacturing? We’re seeking a highly skilled Validation Specialist to support critical projects, leading system validation from design through commissioning and qualification.
What You’ll Do:
- Lead and execute Installation, Operational, and Performance Validation (IV, OV, PV) protocols for key systems and processes.
- Author and review validation documentation including Project Quality Masterplans (PQMPs), Validation Plans (VPLs), and other essential records.
- Own Change Requests (CRs) related to validation projects and ensure compliance with regulatory and corporate standards (FDA, ICH, 21 CFR Part 11, GAMP5).
- Perform root cause analysis and lead investigations for validation failures and non-conformities.
- Participate in FAT/SAT commissioning for equipment, automation systems, and processes, transitioning these systems into operational ownership.
- Identify process improvements prior to placing equipment or systems under change control.
- Provide guidance and expertise to team members as a subject matter expert.
- Support contractor oversight, scheduling, and budget tracking as needed.
Qualifications & Experience:
- BA/BS in Engineering, Computer Science, or a related technical field (MA/MS/MBS preferred).
- Minimum 7 years of validation or quality experience in pharmaceutical manufacturing.
- Deep understanding of regulatory requirements, GMP concepts, and industry standards.
- Proven ability to author technical documentation, execute validation protocols, and perform compliance reviews.
- Strong leadership, project management, and interpersonal skills, with experience managing multiple priorities and teams.
- Experience with TIMS is required.
What We Value:
- Empathy, inclusivity, and team building.
- Ability to coach, mentor, and inspire others.
- Agility, accountability, and innovative problem solving.
Physical Requirements:
- Ability to handle equipment or supplies up to 33 lbs.
- Stationary work (sitting/standing) ~50% of the time.
- May require work at elevated heights or around odorous/hazardous materials.
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