Process Validation Engineer

LAPORTE L.C.C.•King of Prussia, PA

5d•Onsite

About The Position

The Process & Validation Engineer is responsible for supporting the validation of various systems across the pharmaceutical, biopharmaceutical, and medical device manufacturing sectors. The Process & Validation Engineer will ensure equipment, systems, and validation programs are compliant with a client’s global/site standards and industry practices. The Process & Validation Engineer will live near King of Prussia, PA. They will be motivated to grow and excel with the support and direction from an interdisciplinary team of engineers. Become part of a supportive work environment that emphasizes team culture and empowering engineers with more responsibility, professional growth, and a work-life balance.

Requirements

Bachelors degree in engineering field or relevant equivalent.
Minimum 5 years of prior experience preparing and executing equipment qualification documents (IQ/OQ/PQ) required.
Excellent knowledge of the Current Good Manufacturing Practices.
Excellent communication skills - verbal, written, listening and interpersonal with the ability to transfer knowledge to others.
Strong technical knowledge, relationship management, organizational planning, and project management skills.
Ability to demonstrate a sense of urgency, flexibility, and accountability.
Flexibility to travel to the client site as required.

Nice To Haves

Prior experience performing GxP risk assessments such as Functional Risk Assessments (FRA) or Failure Mode and Effect Analysis (FMEA).
Experience in Aseptic Processing.
Familiarity with Computerized Systems Validation and ISPE GAMP5 and 21 CFR Part 11.

Responsibilities

Carry out all aspects of a validation project for our clients including: authoring and/or executing Validation Master Plans (VMP), User Requirements Specifications (URS), Risk Assessments (RA), Design Qualification (DQ), Factory Acceptance Tests (FAT), Site Acceptance Tests (SAT), Commissioning, Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and Process Validation (PV) protocols/reports in accordance with corporate and departmental procedures.
Develop Validation Master Plans outlining the validation strategy, scope, and timelines for the project.
Oversee the creation, review, and approval of validation protocols, reports, and other documentation required for validation activities.
Conduct Risk Assessments to identify potential validation issues and develop mitigation strategies to address them.
Oversee the execution of validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for equipment and systems within the QC building.
Collaborate with the commissioning team to ensure a seamless transition from construction to operation, verifying that systems and equipment are installed correctly and function as intended.
Provide technical input with respect to Standard Operating Procedures (SOP) development. Revise or develop SOPs in compliance with industry standards and cGMP.
Support client Quality Assurance (QA) compliance teams by initiating change controls, documenting deviations, and contributing to the implementation of CAPA (Corrective and Preventive Actions) within validation activities.
Perform Periodic Review for various validated systems including computerized systems, laboratory equipment, manufacturing equipment, and infrastructure systems. Analyze information, draw the right conclusions based upon technical knowledge of the systems, and work effectively with different groups across site to determine status, gaps, and corrective actions.
Maintain up-to-date knowledge of validation requirements, practices, and procedures and coach other members of the team participating in validation activities.
Maintain up-to-date knowledge of current GP (Good Practices, e.g. GMP/GLP) regulations, guidelines within North America (Health Canada, US Food & Drug Administration) and EU Eudralex.
Maintain effective client relationships and act as a primary point of contact.
Ensure that projects are implemented in accordance within the agreed scope, timelines and budget.