Validation Engineer IV Job at PCI Pharma Services (Bedford)

Job Description

The Validation Engineer IV performs an array of well-defined validation activities in support of cGMP pharmaceutical/medical device contract manufacturing across multiple facilities. In collaboration with validation management, the engineer provides guidance to internal project teams and external validation firms on large/complex validation/qualification initiatives and ensures project schedules are met. Complies with requirements of the Safety Program, including PCI Health and Safety mandates and OSHA requirements. In carrying out duties, contributes and promotes a positive and equitable working environment emphasizing the PCI Values: Customer Focus, Innovation, Integrity, Collaboration, and Superior Performance.

Job Responsibility

Author validation plans
oversee and provide direction in the development of specifications for user requirements, functional requirements, and design requirements, trace matrices, validation summary reports and test protocols for installation, operation, performance of equipment, functional requirements, risk assessments, and IQ/OQ/PQ Protocols
Review and approve commissioning, qualification and validation related system lifecycle documentation (user requirements, functional and design specifications, commissioning and qualification protocols)
Provide direction on equipment/process change control development (equipment, utilities, facilities, and processes) used to develop and manufacture products in a cGMP environment
Work closely with other validation department personnel as well as cross-functionally with Manufacturing, Engineering, Critical Utilities, Quality Assurance, and project management to achieve all project deliverables
Perform a periodic review of systems to monitor the validation status of the system as well as write and develop validation SOPs
Help define validation strategies based on regulations, guidance documents, industry practice and experience
Assist management with mentoring and training of colleagues on policies and procedures including the requirements for validation
Team representative on validation projects leading by example on significant projects requiring complex technical solutions
Develop and recommend science-based solutions with a focus on continuous improvement and compliance
Perform risk assessment and mitigation steps to achieve attainment and maintenance of a validated state of compliance for all equipment, utilities, processes, materials, and facilities
Coordinate and execute validation protocol activities with consistent and effective communication with affected departments
working autonomously while keeping manager regularly updated
Work in a highly independent fashion, with minimal to no direction in the execution of duties, while keeping team mates and manager informed and providing guidance to other engineers as needed
Write protocols and technical study approaches
Review document changes for validation impact
Review deviation reports for validation impact
Review and approval of change controls
Propose corrective actions to validation manager and appropriate departments and implement the required changes

Requirements

Bachelor’s degree in Engineering or related scientific discipline required with a minimum of eight (8) years of Pharmaceutical industry experience or combination of work experience in Validation, Quality, Production, or Engineering
Experience in pharmaceutical or biopharmaceutical environment in operations/engineering/manufacturing/quality environments
Combination of equipment qualification, process validation, or cleaning validation is acceptable
QA pharmaceutical experience also preferred
Direct Validation experience with pharmaceutical or biopharmaceutical processes including the development of strategies, master plans, protocols and reports
Validation experience with the following is highly preferred: Thermal characterization, Vacuum physics, Heat and mass transfer, Formulation, Aseptic Filling and Lyophilization. Sterilization
Experience in multiple regulatory inspections and knowledgeable in current industry standards and regulatory trends as they pertain to Validation of pharmaceutical or biopharmaceutical processes

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Validation Engineer IV

Job Description

Job Responsibility

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