GMP Validation & Calibration Specialist

Accupac, Inc.; Pennsylvania; On-site; USD 44,000 - 60,000; Full time

Benefits offered by this job

Medical coverage

Dental coverage

Vision coverage

HSA

Life Insurance with supplemental plan

Pet Insurance

PTO and holidays

401(k) with match

Job summary

Accupac, Inc. is seeking a Validation Associate I & II for our Mainland, PA location to perform validation activities and maintain documentation in a cGMP environment. You will write and execute IQ/OQ testing protocols and collaborate with Quality Systems and Operations teams.

The role requires strong organizational and communication skills, attention to detail, and proficiency in Word, Excel, and PowerPoint. Bachelor’s degree or 1–4 years’ related experience preferred.

Qualifications

• Bachelor’s degree or 1–4 years of experience 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.
• Strong attention to detail and ability to work independently.
• Proficiency in Microsoft Word, Excel, and PowerPoint.

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

Organizational skills

Documentation skills

English communication

Attention to detail

Education

Bachelor’s degree preferred or equivalent in cGMP environment

Tools

IQ/OQ/PQ validation protocols

Job description

Accupac, Inc. is seeking a Validation Associate I & II for our Mainland, PA location to perform validation activities and maintain documentation in a cGMP environment. You will write and execute IQ/OQ testing protocols and collaborate with Quality Systems and Operations teams.

The role requires strong organizational and communication skills, attention to detail, and proficiency in Word, Excel, and PowerPoint. Bachelor’s degree or 1–4 years’ related experience preferred.