Technical PM
Primary stack
Job description
About the Position
We are seeking an experienced Technical Project Manager with strong Computer System Validation (CSV) and compliance knowledge to lead validation and quality compliance activities for computerized manufacturing systems within a GMP-regulated pharmaceutical environment. The role requires effective project governance, stakeholder management, risk oversight, and coordination of cross-functional teams supporting manufacturing automation and digital transformation initiatives.
Responsibilities
- Lead and coordinate CSV and compliance activities for manufacturing system projects, ensuring alignment with GxP requirements, internal procedures, and regulatory expectations.
- Provide governance and oversight for validation lifecycle deliverables, including planning, review, approval coordination, and compliance tracking.
- Drive project execution across multiple stakeholders, ensuring timely delivery of compliance, validation, and qualification activities.
- Guide project teams on SDLC, CSA (Computer Software Assurance), qualification, risk-based validation, change control, and compliance processes.
- Facilitate risk assessments, issue resolution, CAPA tracking, and change management activities.
- Act as the primary liaison between business, quality, validation, engineering, and IT teams to ensure successful project delivery.
- Monitor project timelines, dependencies, risks, and compliance milestones while providing regular status updates to leadership.
Experience
Experience working with or supporting projects involving one or more of the following:
- DeltaV Distributed Control Systems (DCS)
- PLC Platforms (Rockwell and/or Siemens)
- Manufacturing Process Historians
- Laboratory Automation Systems
- Manufacturing Execution Systems (MES)
Requirements
- Strong knowledge in Computer System Validation (CSV)
- Expertise in compliance processes
- Proven experience in project governance
- Skilled in stakeholder management
- Proficient in risk oversight
- Ability to coordinate cross-functional teams
We Expect You to Have
- Experience with DeltaV Distributed Control Systems (DCS)
- Experience with PLC Platforms (Rockwell and/or Siemens)
- Experience with Manufacturing Process Historians
- Experience with Laboratory Automation Systems
- Experience with Manufacturing Execution Systems (MES)
About the Company
The Workly s.r.o.
4D CENTER, Kodaňská 1441/46,
101 00, Praha 10.
Contact
[email protected]
- 420 775 371 991
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