Senior Validation Engineer - Parsippany, United States - Katalyst HealthCares & Life Sciences

Description

Responsibilities:
Lead and manage multiple commissioning / qualification / validation activities performed at facility with minimal supervision.

Equipment Qualification / Re-Qualification (IQ, OQ, PQ) for process equipment, QC equipment, packaging equipment, clean utilities.

Cleaning Verification / Validation studies for transferred products.

Media Fills / process simulations protocols.

Engineering protocols to support packaging validation / shipping study activities.

Trackwise deviations and qualification / validation deviations related to equipment / instrument, cleaning, and process non-conformances.

Assist in execution of Process Validation and Engineering studies.

Review commissioning, qualification, validation projects performed by Validation Specialists and / or Validation contractors.

Generate Validation Master Plans (VMPs) and Risk Assessments related to large level qualification projects.

Monitor and track protocol and report status.

Complete GMP Impact Assessments, System Component Criticality Reviews, Traceability Matrixes, Design Qualification, Vendor documentation checklists, and final handover of documents to Operations with minimal supervision.

Mentor and train junior level Validation Specialists on various validation tasks.

Plan and complete commissioning, qualification, and validation activities performed in facility.

Complete Trackwise deviations and qualification / validation deviations related to equipment / instrument, cleaning, and process non-conformances, and assist Validation Specialist with same activities.

Resolve observation / CAPAs generated from internal and external cGMP audits related to Validation, Qualification, and Commissioning studies.

Participate and able to answer questions during intern and external audits, as needed.

Close change controls, CAPAs, and investigations, as well as ensure deviations, CAPAs, and change controls issued to the department(s) are tracked (closed on time, or extended if necessary.)

Prepares Final Reports summarizing the results of executed Validation / Qualification studies and address comments and questions from reviewers / approvers.

Assist Production, Engineering, and/ or IT in improving / optimizing performance of process / packaging equipment.

Update yearly Validation Master Plan.


Requirements:
Bachelor's degree in engineering or related field, or equivalent combination of education and work-related experience, required.

Minimum 5 years of hands-on experience in validation (PV, CV), specifically within the pharmaceutical sector.

Subject matter expert in at least two (2) of the Qualification / Validation subjects specified below

Sterile Process Equipment Qualification

Packaging Equipment Qualification

Media Fills

Utilities Commissioning / Qualification

Cleaning Verification / Validation

Process Validation

QC Equipment Qualification

Computer System Validation

Environmental Monitoring Qualification of Classified Areas

Understanding of validation principles, current Good Manufacturing Practices (cGMP), and applicable regulatory requirements

Proficiency in equipment and process validation, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).

Excellent problem-solving and analytical skills.

Strong communication and teamwork abilities.

Ability to work independently in a timely manner.

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