Sterile Validation Specialist

Penn Life Sciences, Inc.; False Pass (AK); On-site; USD 42,000 - 55,000; Full time

Job summary

Penn Life Sciences, Inc. is seeking a Validation Associate to support commissioning, qualification, validation, requalification, and documentation activities within a sterile injectable manufacturing facility.

You will work cross-functionally with Manufacturing, QA, Engineering, Facilities, and Microbiology to ensure regulatory compliance and maintained validated states. The role focuses on executing protocol activities, preparing materials, recording data, and contributing to the lifecycle of

Qualifications

• Associate degree or technical diploma required.
• Bachelor’s degree in Engineering, Life Sciences, Chemistry, Biology or related field strongly preferred.
• Experience following procedures and maintaining controlled documentation is desirable.

Responsibilities

• Execute qualification, validation, requalification, and verification activities per approved protocols.
• Prepare validation areas, materials, instruments, data sheets, and supporting documentation for scheduled validation activities.
• Record and submit validation observations and results with Good Documentation Practices.
• Support validation across facilities, utilities, equipment, cleaning, sterilization, and computerized systems.
• Identify discrepancies and escalate issues promptly.
• Maintain validation trackers and requalification schedules.

Skills

cGMP knowledge

Good Documentation Practices

Data integrity

Validation lifecycle

IQ/OQ/PQ

Attention to detail

Education

Associate degree or technical diploma

Bachelor’s degree in Engineering or Life Sciences

Job description

Penn Life Sciences, Inc. is seeking a Validation Associate to support commissioning, qualification, validation, requalification, and documentation activities within a sterile injectable manufacturing facility.

You will work cross-functionally with Manufacturing, QA, Engineering, Facilities, and Microbiology to ensure regulatory compliance and maintained validated states. The role focuses on executing protocol activities, preparing materials, recording data, and contributing to the lifecycle of