PCI Pharma Services · 1 day ago
Process Validation Engineer III - IV
Bedford, NH, USA
Full-time
Hybrid
Senior Level
7+ years expPCI Pharma Services is a company that focuses on life-changing therapies and has a global impact in the biopharma industry. They are seeking a Process Validation Engineer IV to guide teams and perform validation activities in support of pharmaceutical and medical device contract manufacturing, ensuring compliance with cGMP standards and supporting project deliverables.
BiotechnologyHealth CareLife ScienceMedical DevicePackaging ServicesPharmaceutical
Responsibilities
Develop and support the detailed project plans and timelines for the execution of process validation activities
Prepare validation & change control documentation, including protocols, summary reports, etc
Author Process Performance Qualification/ verification validation plans; this includes the development of client specific process requirements and specifications drafts to execute process performance qualifications, process simulation media fill protocols. Also compile trace matrices, perform data analysis, draft validation protocol discrepancy reports and draft process validation summary reports
Author and perform the technical review of deviations and planned deviations, change controls, perform process monitoring (manufacturing data summary and analysis, data presentation), perform activities for lot release (assess deviations and process changes)
Participate in client and Regulatory Audits. Work on CAPA and QS with minimal oversight to achieve timely results
Assist with determining impact of change control on qualified process and aseptic operations
Work closely with other validation department personnel and cross-functionally with MTS, Manufacturing, Engineering, QC, Quality Assurance, and project management to achieve all project deliverables
Assist management with mentoring and training of colleagues on policies and procedures including the requirements for validation. Perform all functions associated with process validation support
Develop and recommend science-based solutions with a focus on continuous improvement and compliance
Perform risk assessment and mitigation steps to achieve validation requirements and ensure each process remains in a validated state of compliance by compiling and analyzing data for continued process verification
Coordinate and execute validation protocol activities with consistent and effective communication with affected departments; working autonomously while keeping the manager updated regularly
Work in a highly independent fashion, with minimal to no direction in the execution of duties, while keeping teammates and manager informed and providing guidance to other engineers as needed
Write process validation and process simulation media fill protocols and technical study approaches
Qualification
Required
Experience in pharmaceutical or biopharmaceutical environment in operations/engineering/manufacturing/quality environments
Proficient in the development and execution of PPQs. Review commissioning, qualification and validation related system lifecycle documentation (user requirements, functional and design specifications, commissioning and qualification protocols)
Combination of equipment qualification, process validation, or cleaning validation is acceptable; QA pharmaceutical experience also preferred
Validation experience with the following is highly preferred: Vacuum physics, Heat and mass transfer, Formulation, Aseptic Filling and Lyophilization, Steam Sterilization, data analysis and statistics
Engagement and knowhow with regulatory inspections and knowledgeable in current industry standards and regulatory trends as they pertain to Validation of pharmaceutical or biopharmaceutical processes
Bachelor of Science degree in Chemical Engineering, Biochemistry, Biology or related scientific discipline required with a minimum of 7 – 10 years of Pharmaceutical industry experience or combination of work experience in Validation, QA, MFG, MTS, Process Development or Engineering
Highly organized professional who is accustomed to working in a result oriented-focused, dynamic CMO environment
Professional and collaborative team player must have excellent interpersonal skills
Honesty, integrity, respect and courtesy with all colleagues. Ability to inspire others to strive for excellence
Is driven to meet goals with minimal supervision
Knowledge of Industry guidelines (ISPE, PDA), US and international regulations (FDA, ICH, ISO, EMA) for validation of GMP fill finish facilities. Understanding of the competitive landscape of the medical device, pharmaceutical, and biotechnology industry
Possess strong knowledge of Process Performance Qualification /Validation practices, including applicable regulations
Excellent technical writing, verbal communication and presentation skills
Proven capabilities to successfully bring cross-functional teams together to achieve goals through strong positive influence and leadership direction
Proficiency in Microsoft Office including Word, Excel, Power Point, Project
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