Role Overview:
The Capital Project Manager will lead the planning, execution, and oversight of automation projects focused on DeltaV Distributed Control Systems (DCS) and Programmable Logic Controllers (PLCs) within pharmaceutical manufacturing environments. This role involves managing the integration and upgrading of automation systems, ensuring GMP compliance, and delivering high-quality results in collaboration with cross-functional teams.
Key Responsibilities:
Project Planning and Execution:
- Oversee automation projects involving DeltaV DCS and PLC-based systems, including complex equipment upgrades and system integrations.
- Develop and manage detailed project plans, schedules, and budgets while ensuring alignment with regulatory and business objectives.
- Collaborate with Quality teams to draft, submit, and gain approval for change controls, ensuring all tasks are completed to meet project milestones.
Automation Systems Management:
- Lead the design, specification, and installation of DeltaV and PLC systems, ensuring alignment with manufacturing and regulatory requirements.
- Oversee the programming, configuration, and testing of control systems, including hardware and software components.
- Coordinate with vendors for technical specifications, procurement, and implementation of new systems or system upgrades..
Stakeholder Collaboration:
- Work closely with cross-functional teams, including engineering, quality, operations, and IT, to schedule automation activities and minimize operational disruptions.
- Communicate project timelines and coordinate system outages with affected departments.
Technical Documentation:
- Redline automation system drawings during project execution and collaborate with the CAD team for updates to reflect as-built conditions.
- Compile and organize system documentation, including Functional Specifications (FS), Design Specifications (DS), and Turnover Packages (TOPs).
System Commissioning and Qualification:
- Lead commissioning activities for DeltaV and PLC systems, including Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), and validation protocols.
- Oversee system qualification processes such as Installation Qualification (IQ) and Operational Qualification (OQ), ensuring compliance with GMP standards.
- Execute CIP/SIP and wet testing to validate system functionality.
Budget and Vendor Coordination:
- Scope automation projects, gather pricing, and develop cost estimates for DeltaV and PLC implementations or upgrades.
- Manage vendor relationships, ensuring deliverables meet project specifications, timelines, and budgets.
Qualifications:
Education:
- Bachelor’s degree in Engineering (Electrical, Automation, Controls, or related fields) or equivalent experience.
Experience:
- Minimum of 5 years managing engineering projects involving DeltaV and PLC systems within GMP pharmaceutical environments.
Skills & Competencies:
- In-depth knowledge of DeltaV DCS, PLC programming, and integration with GMP manufacturing processes.
- Proficiency in managing change controls and documentation in compliance with pharmaceutical industry regulations.
- Strong technical understanding of automation systems, including networking, instrumentation, and HMI/SCADA interfaces.
- Excellent written and verbal communication skills to coordinate with cross-functional teams and external vendors.
- Ability to manage multiple projects simultaneously, ensuring high-quality execution and adherence to safety standards.
Preferred Qualifications:
- Familiarity with validation lifecycle processes for automation systems.
- Experience with advanced automation tools such as Batch Processing, S88 standards, and OPC communication protocols.
