Validation Specialist: IQ/OQ/PQ & GMP Compliance

Accupac

Pennsylvania

On-site

USD 50,000 - 60,000

Full time

10 days ago

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Benefits offered by this job

Medical, Dental, and Vision insurance
Health Savings Account
401(k) Retirement Plan with Company 5%
Paid Time Off (PTO)
10 Paid Holidays
Health Advocacy Programs

Job summary

Accupac is seeking a Validation Associate to ensure processes and equipment meet quality and regulatory standards at our Mainland, PA site. The role emphasizes documenting validation activities and coordinating with QA, operations, and management to keep products safe and compliant.

You’ll write protocols, perform IQ/OQ testing, and maintain validation reports while supporting calibration and maintenance programs in a regulated environment.

Qualifications

  • Bachelor’s degree preferred or 1–4 years in a cGMP-regulated environment.
  • Strong organizational and documentation skills.
  • Experience with IQ/OQ/PQ validation protocols.
  • Familiarity with manufacturing, packaging, and cleaning processes.
  • Ability to read, write, and communicate effectively in English.

Responsibilities

  • Review customer documentation to assess required validation activities.
  • Write and execute protocols, perform IQ/OQ testing, and maintain validation reports.
  • Collaborate with Quality Systems, Project Management, and Operations teams.
  • Manage validation documentation in compliance with SOPs and GMP standards.
  • Support calibration and preventative maintenance tracking.
  • Maintain the Calibration Management database and ensure timely PMs and calibrations.
  • Investigate and resolve validation deviations and errors with QA and departmental managers.

Skills

Attention to detail
Organizational skills
MS Office proficiency
English communication

Education

Bachelor’s degree preferred or 1–4 years in a cGMP-regulated environment

Tools

IQ/OQ/PQ protocols

Job description

Accupac is seeking a Validation Associate to ensure processes and equipment meet quality and regulatory standards at our Mainland, PA site. The role emphasizes documenting validation activities and coordinating with QA, operations, and management to keep products safe and compliant.

You’ll write protocols, perform IQ/OQ testing, and maintain validation reports while supporting calibration and maintenance programs in a regulated environment.

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