Validation Specialist

Validation Specialist

The Validation Specialist will support the qualification of new and existing packaging equipment at the Allentown site. The role is responsible for developing, executing, reviewing, and closing validation documentation, with particular emphasis on IQ, OQ, and PQ protocols for pharmaceutical packaging and inspection equipment. The successful candidate will combine strong technical writing and hands-on protocol execution experience with practical knowledge of GMP requirements, packaging operations, and equipment qualification.

Key responsibilities include developing, reviewing, executing, and closing equipment qualification protocols and reports, supporting the complete validation lifecycle, applying risk-based validation principles, coordinating protocol execution with various stakeholders, documenting protocol discrepancies and deviations, developing and maintaining supporting documentation, managing multiple validation assignments, and performing all work in accordance with approved procedures, GMP requirements, data integrity expectations, and site safety requirements.

Required qualifications include a bachelor's degree in engineering or science, at least five years of equipment validation or qualification experience in a cGMP-regulated pharmaceutical manufacturing or packaging environment, experience with qualification of automated primary or secondary packaging equipment, practical knowledge of validation lifecycle documentation, strong technical writing, verbal communication, organizational, and stakeholder coordination skills, and proficiency with Microsoft Word and Excel for documentation, data review, issue tracking, and reporting.

Preferred experience includes developing or reviewing equipment specifications, functional design specifications, FMEAs, FAT/SAT documentation, commissioning protocols, SOPs, and work instructions, supporting equipment installation, automation integration, operational readiness, and packaging equipment troubleshooting, supporting clinical and commercial packaging operations and multiple concurrent equipment qualification projects, coordinating validation activities with equipment vendors, contractors, Quality, Engineering, and Operations, and a client-focused, collaborative approach with the ability to communicate effectively across technical and nontechnical functions.