Description:
We are seeking an experienced Automation Project Manager to lead key initiatives within a pharmaceutical manufacturing environment. This role offers the opportunity to manage automation projects end-to-end, drive compliance, and deliver continuous improvements across production systems.
Key Responsibilities
- Lead automation strategy, development, and implementation, with a strong focus on Siemens PCS 7 DCS.
- Manage projects through the full lifecycle: design, commissioning, qualification, and handover.
- Act as SME for Siemens PCS 7, including architecture, configuration, programming, troubleshooting, and optimization.
- Ensure systems are fully compliant with cGMP, GAMP5, FDA 21 CFR Part 11, and related regulatory standards.
- Collaborate with cross-functional teams (Engineering, IT, Quality, Validation, Maintenance, Operations) to support manufacturing performance.
- Provide leadership to automation engineers and contractors, offering technical guidance, mentoring, and performance oversight.
- Develop and maintain technical documentation: URS, FDS, SDS, FAT/SAT protocols, and validation deliverables.
- Support digitalization and process improvements in automation, data integrity, and control systems.
- Troubleshoot and resolve automation issues, ensuring minimal production downtime.
- Oversee integration of PCS 7 with MES, historians, and enterprise systems.
Requirements
- Proven track record in automation project management within pharma/biotech manufacturing.
- Strong hands-on expertise with Siemens PCS 7 DCS.
- Deep knowledge of GxP, validation, and automation compliance frameworks.
- Excellent leadership, communication, and cross-functional collaboration skills.
- Ability to deliver results in a fast-paced, regulated environment.