Validation Associate

Accupac, Inc.; Pennsylvania; Presencial; USD 44.000 - 60.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical coverage

Dental coverage

Vision coverage

HSA

Life Insurance with supplemental plan

Pet Insurance

PTO and holidays

401(k) with match

Descripción de la vacante

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.

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

Organizational skills

Documentation skills

English communication

Attention to detail

Educación

Bachelor’s degree preferred or equivalent in cGMP environment

Herramientas

IQ/OQ/PQ validation protocols

Descripción del empleo

Job Title

Validation Associate I & II

Location

Mainland, PA 19451

Salary and Compensation

• Salary Range: $44,000.00 - $60,000.00
• Bonus: Exempt employees eligible for a bonus in accordance with Accupac’s Bonus Plan.
• Compensation will be determined based on experience, education, and market data.

Benefits

• Medical, Dental, and Vision insurance
• Health Savings Account
• Life Insurance with Optional Supplemental Plan
• Pet Insurance
• Short-Term Paid Disability
• 401(k) Retirement Plan with Vested Company Match Contribution
• Paid Time Off (PTO)
• 10 Paid Holidays
• Health Advocacy Programs

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

Qualifications

• Bachelor’s degree preferred 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