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Technical Project Manager – Controls & Data Systems We are seeking a Technical Project Manager with a strong engineering background and proven project management expertise to lead initiatives involving control systems, data acquisition, and pharmaceutical manufacturing processes. This role is critical in supporting late-stage development, technical transfer, and commercialization, with a strong focus on project execution, compliance, and customer engagement. The ideal candidate will combine technical depth with project leadership skills, thrive in a fast-paced CDMO environment, and ensure successful delivery of complex pharmaceutical programs.
Job Responsibility
Lead technical projects from initiation through completion, ensuring scope, schedule, and budget adherence
Develop and maintain project plans, risk assessments, and resource allocation strategies
Coordinate cross-functional teams including R&D, Quality, Regulatory, and Operations
Ensure compliance with GMP, FDA, and regulatory requirements throughout project execution
Oversee design, implementation, and optimization of control systems and data acquisition platforms supporting pharmaceutical manufacturing
Support technical transfer activities for transdermal patch and metered dose inhaler (MDI) programs
Guide system integration, testing, and validation activities to meet industry standards
Apply QbD principles and statistical tools (DoE, FMEA, Gage R&R) to drive data-driven decisions
Act as primary project contact for clients, supporting project kick-offs, technical reviews, and troubleshooting
Communicate complex technical concepts clearly and professionally to external stakeholders
Support client audits and regulatory inspections as a subject matter expert
Identify and implement improvements in process robustness, product quality, and operational efficiency
Contribute to Lean initiatives and best practice sharing across programs
Requirements
Bachelor's or Master's degree in Engineering (Chemical, Electrical, Mechanical, Biomedical, or related field)
Project Management Professional (PMP) certification or equivalent required
7+ years of experience in pharmaceutical manufacturing with exposure to transdermal patch and/or MDI programs
Strong technical background in control systems, automation, and data acquisition technologies
Proven success in managing technical projects within a CDMO or regulated manufacturing environment
Excellent communication, leadership, and stakeholder management skills
Experience with cGMP environments and combination product requirements
Nice to have
Familiarity with coating, laminating, die-cutting (for patches), and filling/crimping (for MDIs)
Experience preparing CMC documentation for regulatory submissions (NDA/ANDA)
Lean Six Sigma or continuous improvement certification is a plus