Validation Specialist

Pinnaql, Inc.; Allentown (Lehigh County); On-site; USD 75,000 - 95,000; Full time

Job summary

Validation & Engineering Group, Inc. in Allentown is seeking a Validation Specialist to support qualification of packaging equipment. The role focuses on developing, executing, reviewing, and closing IQ/OQ/PQ protocols with strong GMP and data integrity practices.

The ideal candidate has 5+ years of cGMP equipment validation experience, excellent technical writing skills, and the ability to coordinate with Quality, Engineering, and Operations to protect schedules and quality.

Qualifications

• Bachelor’s degree in engineering or science.
• At least 5 years of equipment validation in a cGMP pharmaceutical environment.
• Experience independently developing IQ/OQ/PQ protocols.
• Knowledge of validation lifecycle documentation, change control, deviation management, CAPA, risk assessment, and traceability.

Responsibilities

• Develop, review, execute, and close IQ/OQ/PQ documentation for packaging equipment.
• Coordinate protocol execution with Engineering, Quality, Operations, and vendors.
• Maintain validation documentation, URS, specs, change controls, SOPs, and records.
• Escalate risks or blockers promptly and manage multiple assignments.
• Perform work in compliance with GMP, data integrity, and site safety requirements.

Skills

IQ/OQ/PQ protocols

Technical writing

GMP compliance

Data integrity

Stakeholder coordination

Excel & Word

Education

Bachelor’s degree in engineering or science

Tools

Microsoft Word

Microsoft Excel

Job description

Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to work under the highest ethical standards for the following position:

• Validation Specialist

Position Summary

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

• Develop, review, execute, and close equipment qualification protocols and reports, including IQ, OQ, and PQ documentation for primary and secondary packaging equipment.
• Support the complete validation lifecycle, as applicable, including system impact assessments, user requirements specifications, risk assessments, validation plans, traceability matrices, FAT/SAT, commissioning, protocol deviations, and summary reports.
• Apply risk-based validation principles to define appropriate testing requirements, acceptance criteria, sampling, traceability, and documented evidence.
• Coordinate protocol execution with Engineering, Quality, Operations, Maintenance, Automation, equipment vendors, and other stakeholders while minimizing disruption to production activities.
• Document protocol discrepancies and deviations clearly and support investigations, root-cause evaluations, corrective actions, CAPAs, and the timely resolution of open items.
• Develop, maintain, or review supporting documentation, including URS, equipment specifications, change controls, SOPs, work instructions, drawings, and engineering records.
• Maintain accurate project status, action lists, validation schedules, and documentation packages, and **escalate** risks or blockers promptly.
• Manage multiple validation assignments and adapt quickly to changing site priorities while maintaining quality, compliance, and schedule commitments.
• Perform all work in accordance with approved procedures, GMP requirements, data integrity expectations, and site safety requirements.

Required Qualifications

• Bachelor’s degree in engineering or science.
• At least 5 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.
• Demonstrated experience independently developing and executing IQ, OQ, and PQ protocols for manufacturing or packaging equipment.
• Practical knowledge of validation lifecycle documentation, change control, deviation management, CAPA, risk assessment, and requirements traceability.
• Strong understanding of GMP requirements, good documentation practices, and data integrity expectations.
• Strong technical writing, verbal communication, organizational, and stakeholder coordination skills.
• Ability to investigate and resolve protocol discrepancies while maintaining accurate and complete validation records.
• Proficiency with Microsoft Word and Excel for documentation, data review, issue tracking, and reporting.
• Ability to work on site in Allentown and remain actively engaged in protocol execution and project activities.

Preferred Experience

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

At Validation & Engineering Group, people always come first. We believe that when you're empowered to do your best work, bold ideas thrive and real progress happens. This isn't just a job - it's an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose-driven, supportive team.

Validation & Engineering Group is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.