Sr. Spclst Technical Project Management
Listed on 2026-07-13
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Manufacturing / Production
Automation & Mechatronics Engineer, Systems Engineer
Position Summary
The Technical Project Manager (TPM) is responsible for delivering digital, automation, and data integration scope across capital projects within the Digital Manufacturing Division Manufacturing Value Team portfolio. This role ensures the reliable, compliant, and scalable implementation of process automation and manufacturing digital systems that support facility startup, operational readiness, and sustained manufacturing performance.
The TPM leads defined project scopes or work streams across the full project lifecycle, embedding automation architecture, data integrity, cybersecurity, and validation requirements into project execution. This role works closely with Engineering, Automation, IT, Quality, Manufacturing Operations, and external partners to deliver robust, compliant solutions aligned with cGMP, data integrity, and lifecycle management best practices.
Key Responsibilities and Expectations- Lead end‑to‑end delivery of digital and automation scope across capital project phases, including FEL, detailed design, construction, commissioning, and qualification.
- Manage scope, schedule, cost, risks, and dependencies to ensure alignment with project objectives and milestones.
- Monitor project performance and proactively identify and resolve issues impacting delivery.
- Deliver process automation, MES, and data integration solutions, including DCS, PLC‑based platforms, historians, and reporting/analytics tools.
- Support development of user requirements, functional/design specifications, and validation deliverables.
- Ensure technical solutions meet quality, data integrity, cybersecurity, and lifecycle management requirements.
- Coordinate system integration across automation platforms, OEM equipment, and enterprise data systems.
- Support FAT/SAT, installation, commissioning, and qualification of automation systems.
- Partner with Engineering, Automation, IT, Quality, Operations, vendors, and system integrators to support aligned execution.
- Support stage‑gate governance, project reviews, and accurate status reporting to stakeholders and leadership.
- Ensure systems are delivered in a validated, compliant state and support readiness for startup and transition to operations.
- Operate within established governance frameworks while independently driving day‑to‑day execution.
- Escalate complex risks, cross‑project impacts, and constraints as needed.
- Apply technical judgment, structured problem‑solving, and root‑cause analysis to resolve issues.
- Successful delivery of digital and automation scope aligned with project schedule, budget, and quality expectations.
- Effective integration and performance of automation and manufacturing systems.
- Clear and proactive communication of project status, risks, and issues.
- Contribution to successful facility startup, validation, and operational readiness.
- Bachelor's degree in Engineering, Computer Science, or a related technical discipline, plus a minimum of 5 years of relevant technical support or manufacturing automation experience, or equivalent related experience.
- Experience supporting delivery of automation or digital scope within pharmaceutical, biotech, or regulated manufacturing environments.
- Working knowledge of automation systems (DeltaV, PLC/SCADA) and manufacturing digital platforms (MES, historians, data integration).
- Demonstrated ability to manage project scope, schedule, deliverables, and cross‑functional coordination.
- Experience supporting capital projects across lifecycle phases, from FEL through commissioning and qualification.
- Familiarity with cGMP, validation, data integrity, and quality systems for computerized systems.
- Experience supporting system integration, commissioning, and qualification of automated equipment.
- Experience working with vendors, system integrators, and global cross‑functional teams.
- Programming experience with Ladder Logic, Sequential Function Charts, Python, and/or other scripting languages for automation, testing, and reporting.
- Knowledge of S88 batch standards.
- Experience in biologics, vaccine, or bulk sterile manufacturing facilities strongly preferred.
- OT/IT experience, including industrial networking, virtualization (e.g., VMs), databases/historians, and basic system administration.
- Experience with electronic validation and quality systems (e.g., Kneat/eVal, Veeva).
- Measurement Analysis
- Portfolio, Programme, and Project Support
- Program Management
- Risk Management
- Stakeholder Relationship Management
- Waterfall Model
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees.
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