Principal Engineer, Global Technical Operations – Engineering & Innovation

PCI Pharma Services

. Act as subject matter expert in isolated or RABS sterile fill finishing and lyophilization equipment and operations .

Posted 10/2/2026full-timeBedford • New Hampshire • United StatesLeadWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in sterile fill finishing and lyophilization processes, with a strong focus on project management, engineering standards, and continuous improvement in a cGMP environment. Proven ability to lead cross-functional teams and manage complex capital projects in the biotechnology and pharmaceutical sectors.

Highest-signal resume keywords

Aseptic ProcessingProject Management Professional (PMP)Continuous ImprovementCGMP Engineering ExperiencePeople Supervision and Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Lyophilization Equipment OperationsSterile Fill FinishingProject Scoping and Cost EstimationTechnical Analysis and TroubleshootingLean ManufacturingPerformance Metrics DevelopmentProcurement and Vendor SelectionFactory/Site Acceptance TestingEngineering Standards DevelopmentAseptic Liquid Filling

Soft Skills

LeadershipCommunicationCollaborationMentoringNegotiation

Certifications & Qualifications

Project Management Professional (PMP)Masters Degree in Engineering

Industry Keywords

BiotechnologyMedical DevicePharmaceuticalCGMPCDMOAseptic ProcessesClean UtilitiesPlant UtilitiesManufacturing Asset AssessmentsStakeholder Relationships

Tech Stack

Tools & technologies

PMP

About the role

Key responsibilities & impact

Act as subject matter expert in isolated or RABS sterile fill finishing and lyophilization equipment and operations
Manage Front End Engineering Design efforts, including project scopes, cost estimates, schedules, project charters, business requirements, and economic evaluations
Manage external engineering partners and internal cross-functional teams
Develop and implement segment-level engineering standards, baseline requirements, governance, standard work, and process documentation
Investigate and recommend alternatives for design, procurement, and installation of equipment and systems
Establish project teams and governance structures
Lead manufacturing asset assessments and site master planning across the segment
Conduct troubleshooting and technical analyses on operational equipment and processes
Organize project governance communications and meetings
Coordinate participation of Global Quality Tech Operations and Site Operations personnel in projects and continuous improvement efforts
Drive Lean Manufacturing and Continuous Improvement culture and develop performance metrics
Lead major capital projects, including technical support through gate processes, pre-construction activities, production coordination, contractor coordination, URS, risk assessments, and safety assessments
Develop system requirements and equipment/building specifications; review external designs; oversee fabrication and lead Factory/Site Acceptance Testing
Provide engineering mentoring to site engineering teams
Support safety, stakeholder relationships, vendors, and continuous improvement initiatives

Requirements

What you’ll need

BS in Chemical, Mechanical, or other Engineering degree from an accredited university is required
Project Management Professional (PMP) certification or similar accreditation is required
Masters degree in Engineering preferred
A minimum of 15 years experience in cGMP related engineering, facilities clean utilities and/or plant utilities, preferably in the biotechnology, medical device, or pharmaceutical industry
A minimum of 10 years experience in a life science contract, development, and manufacturing Organization (CDMO) environment
A minimum of 5 years people supervision and management experience
A minimum of 5 years experience working in procurement environment exhibiting negotiation skills and bidding/proposal evaluation leading to decisions on vendor selection
A minimum of 5 years experience with continuous improvement and hands on innovation ideation platforms
Must have experience in aseptic processing
Experience with aseptic liquid filling of vials, cartridges, and syringes under isolated and RABS environments; aseptic lyophilization; and aseptic processes, including refrigerated and frozen capabilities

Benefits

Comp & perks

Equal Employment Opportunity and Affirmative Action employer
Inclusive workplace committed to fairness, respect, and equal opportunity
Workplace culture supporting belonging and growth