VTI Life Sciences

Life sciences validation and qualification services

Technical Project Manager - Medical Device Validation & Transfer

Project ManagementPosted on Nov 13

Full-timeBaltimore, MD, USANo salary listed

About the Job

Requirements

A bachelor's degree in Engineering, Science, or a related technical discipline is required.
Approximately 15 or more years of relevant validation, manufacturing engineering, process engineering, or quality engineering experience, including substantial medical-device experience, is required.
Demonstrated expertise in medical-device manufacturing and assembly and test process validation is required.
Expertise in Validation Master Plans, risk assessments, and IQ/OQ/PQ strategy and execution is required.
Applied statistical analysis skills are required, including evaluating sampling rationales, process capability, experimental designs, and validation conclusions.
Experience supporting design transfer, technology transfer, manufacturing scale-up, or commercialization is required.
Experience working within an ISO 13485 quality system, Class 8 cleanroom environments, and an FDA-regulated medical-device environment is required.
Ability to work onsite in Baltimore, Maryland, is required.

Responsibilities

Develop and maintain an integrated, task-level validation project plan covering deliverables, owners, resources, prerequisites, dependencies, milestones, approval points, and completion evidence.
Lead several ongoing validation efforts across medical-device manufacturing, assembly, equipment qualification, and supporting processes.
Coordinate development and maintenance of Validation Master Plans, ensuring alignment between validation strategy, process risks, execution priorities, and project schedules.
Partner with the Lead Process Validation Specialist to assess process characterization, technical gaps, and readiness before formal IQ, OQ, and PQ execution.
Apply medical-device and assembly process validation expertise to challenge proposed strategies, acceptance criteria, sampling plans, and statistical rationales.
Coordinate Process Development, Engineering, Manufacturing, Quality Assurance, Quality Control, Regulatory, suppliers, and external laboratories.
Manage critical-path activities, resource constraints, risks, assumptions, issues, dependencies, and recovery plans.
Lead planning, Gantt chart, readiness, progress, and issue-resolution meetings; communicate actionable status and decisions to project leadership.

Desired Qualifications

JMP software knowledge is a plus.
Electrospinning process experience is a significant advantage.
Experience with biomaterials, polymers, fiber manufacturing, or implantable medical devices is preferred.
Experience coordinating packaging, sterilization, test method, cleaning, or facility and utility validation is preferred.
Experience managing external laboratories, contract manufacturers, equipment suppliers, and validation service providers is preferred.
PMP, ASQ CQE, CRE, Lean Six Sigma, or comparable certification is preferred.

Technical Project Manager — Medical Device Validation & Transfer

Location: Baltimore, Maryland
Work Arrangement: Onsite
Engagement Type: Contract / Consulting
Function: Validation / Engineering / Design Transfer
Duration: 3 to 6 months

'Position Overview
VTI Life Sciences is seeking a Technical Project Manager with deep medical device manufacturing and assembly process validation expertise to lead and execute multiple concurrent validation efforts supporting design transfer, manufacturing scale-up, and commercialization.

Candidates must champion lean, scientifically sound, risk-based validation that delivers sufficient objective evidence while avoiding unnecessary testing and documentation.
Candidates who reside in the Baltimore, Maryland area or are willing to relocate are preferred. 75% Onsite availability is required.

Key Responsibilities

Develop and maintain an integrated, task-level validation project plan covering deliverables, owners, resources, prerequisites, dependencies, milestones, approval points, and completion evidence.
Lead several ongoing validation efforts across medical device manufacturing, assembly, equipment qualification, and supporting processes.
Coordinate development and maintenance of Validation Master Plans, ensuring alignment between validation strategy, process risks, execution priorities, and project schedules.
Partner with the Lead Process Validation Specialist to assess process characterization, technical gaps, and readiness before formal IQ, OQ, and PQ execution.
Apply medical device and assembly process validation expertise to challenge proposed strategies, acceptance criteria, sampling plans, and statistical rationales.
Coordinate Process Development, Engineering, Manufacturing, Quality Assurance, Quality Control, Regulatory, suppliers, and external laboratories.
Manage critical-path activities, resource constraints, risks, assumptions, issues, dependencies, and recovery plans.
Lead planning, Gantt Charts, readiness, progress, and issue-resolution meetings; communicate actionable status and decisions to project leadership.

Required Qualifications

Bachelor’s degree in Engineering, Science, or a related technical discipline.
Approximately 15+ years of relevant validation, manufacturing engineering, process engineering, or quality engineering experience, including substantial experience in medical devices.
Demonstrated expertise in medical device manufacturing and assembly and test process validation.
Strong expertise in Validation Master Plans, risk assessments, and IQ/OQ/PQ strategy and execution.
Strong applied statistical analysis skills, including the ability to evaluate sampling rationales, process capability, experimental designs, and validation conclusions. JMP software knowledge is a plus.
Experience supporting design transfer, technology transfer, manufacturing scale-up, or commercialization.
Experience working within an ISO 13485 quality system, Class 8 Cleanroom environments and an FDA-regulated medical device environment..
Ability to work onsite in Baltimore, Maryland.

Preferred Qualifications

Electrospinning process experience is a significant advantage.
Experience with biomaterials, polymers, fiber manufacturing, or implantable medical devices.
Experience coordinating packaging, sterilization, test method, cleaning, or facility and utility validation.
Experience managing external laboratories, contract manufacturers, equipment suppliers, and validation service providers.
PMP, ASQ CQE, CRE, Lean Six Sigma, or comparable certification.
Current residence in the Baltimore area or willingness to relocate.

About the Company

VTI Life Sciences

Life sciences validation and qualification services

VTI Life Sciences provides validation and compliance services across the pharmaceutical and biotech sectors. They offer a full range of services including computer validation, cleaning validation, process validation, clean room certification, temperature mapping, and qualification of processes, equipment, and facilities. Their work involves conducting and documenting tests, audits, and qualifications to show a facility and its systems meet regulatory standards and quality requirements. The company differentiates itself through its ISO 9001:2000 certification, a commitment to quality, personalized support, and a network of offices in San Diego, San Francisco, Boston, and China that enable broad client coverage. The overall goal is to help clients ensure their operations and facilities comply with industry regulations and operate reliably and safely.

Company size: 51-200
Company stage: Not listed
Total funding: Not listed
Headquarters: San Diego, CA
Founded: 1998

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