Process Validation Engineer

1w1 week ago

LAPORTE L.C.C.

King of Prussia, US · Full-time · $110,000 – $150,000

About this role

LAPORTE, a consulting engineering firm with 25 years of experience and a strong presence in North America and Europe, specializes in innovative solutions for the pharmaceutical and food & beverage industries. We seek a Process Validation Engineer to support validation of systems across pharmaceutical, biopharmaceutical, and medical device manufacturing sectors. Ensure equipment, systems, and validation programs comply with client global/site standards and industry practices.

The Process Validation Engineer carries out all aspects of validation projects, including authoring and executing Validation Master Plans, User Requirements Specifications, Risk Assessments, Design Qualification, Factory Acceptance Tests, Site Acceptance Tests, Commissioning, Installation Qualification, Operational Qualification, Performance Qualification, and Process Validation protocols and reports.

Live near King of Prussia, PA, and join an interdisciplinary team of engineers in a supportive work environment that emphasizes team culture. Collaborate with commissioning teams for seamless transitions from construction to operation. Provide technical input on Standard Operating Procedures development and revisions compliant with cGMP.

Support client Quality Assurance compliance teams by initiating change controls, documenting deviations, and contributing to CAPA implementation. Benefit from a flexible work environment valuing work-life balance. Grow professionally with more responsibility and opportunities in a firm with 25 offices and over 480 employees worldwide.

Requirements

Minimum of 5 years of experience required
Experience supporting validation of systems in pharmaceutical, biopharmaceutical, or medical device manufacturing
Knowledge of validation lifecycle including VMP, URS, RA, DQ, IQ, OQ, PQ, and PV
Familiarity with cGMP and industry standards for compliance
Ability to conduct risk assessments and develop mitigation strategies
Experience with commissioning, FAT, and SAT processes
Proficiency in SOP development and revision

Responsibilities

Carry out all aspects of a validation project 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
Develop Validation Master Plans outlining the validation strategy, scope, and timelines
Oversee the creation, review, and approval of validation protocols, reports, and other documentation
Conduct Risk Assessments to identify potential validation issues and develop mitigation strategies
Oversee execution of validation protocols including IQ, OQ, and PQ for equipment and systems
Collaborate with the commissioning team to ensure seamless transition from construction to operation
Provide technical input with respect to Standard Operating Procedures (SOP) development and revise or develop SOPs in compliance with industry standards and cGMP
Support client Quality Assurance compliance teams by initiating change controls, documenting deviations, and contributing to CAPA implementation