PCI Pharma Services · 2 days ago
Validation Engineer IV
Bedford, NH
Full-time
Onsite
Senior Level, Lead/Staff
8+ years expPCI Pharma Services is a company focused on life-changing therapies with a global impact. They are seeking a Validation Engineer IV to perform validation activities in support of cGMP pharmaceutical and medical device manufacturing, ensuring compliance and project schedules are met.
BiotechnologyHealth CareLife ScienceMedical DevicePackaging ServicesPharmaceutical
Responsibilities
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
Qualification
Required
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
Direct Validation experience with pharmaceutical or biopharmaceutical processes including the development of strategies, master plans, protocols and reports
Experience in multiple regulatory inspections and knowledgeable in current industry standards and regulatory trends as they pertain to Validation of pharmaceutical or biopharmaceutical processes
Preferred
Combination of equipment qualification, process validation, or cleaning validation is acceptable; QA pharmaceutical experience also preferred
Validation experience with the following is highly preferred: Thermal characterization, Vacuum physics, Heat and mass transfer, Formulation, Aseptic Filling and Lyophilization. Sterilization
Company
PCI Pharma Services
PCI Pharma Services is a provider of outsourced services to the global pharmaceutical market.
5001-10000 employees
H1B Sponsorship
PCI Pharma Services has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2021 (1)
2020 (2)
Funding
Current Stage
Late StageTotal Funding
unknown2025-07-14Series Unknown
2020-08-24Acquired
2014-08-10Seed
Leadership Team
Gil Valadez
Chief Operating Officer
Recent News
2025-07-22
Company data provided by crunchbase