Job Description
Job Description
Technical Source is seeking a Senior Automation Engineer / Project Manager to support a major pharmaceutical manufacturing client in Rahway, New Jersey.
This role will focus on the automation design, integration, commissioning, and qualification of facility and clean utility systems, including Building Automation Systems (BAS), Environmental Monitoring Systems (EMS), and Purified Water distribution within a GMP manufacturing environment.
This individual will work as part of the Capital Project Automation Delivery Team, supporting expansion projects and ensuring automation systems are implemented, tested, and qualified in compliance with GMP, data integrity, and site automation standards.
Responsibilities
- Support design, configuration, integration, and commissioning of facility automation systems
- Lead automation efforts for BAS, EMS, and Purified Water systems
- Partner with Engineering, Facilities, CQV, Quality, IT, OEM vendors, and system integrators to deliver automation solutions
- Participate in design reviews and system implementation activities
- Develop and execute automation validation and qualification protocols
- Support system testing, troubleshooting, and commissioning activities
- Ensure systems meet GMP compliance, validation, and data integrity standards
- Review and develop logic narratives and automation control strategies
- Interpret P&IDs, electrical schematics, and mechanical diagrams
- Support startup and qualification activities for capital expansion projects
- Troubleshoot automation, instrumentation, and control system issues
Required Qualifications
- Bachelor's degree in Engineering, Science, or related discipline
- 7+ years of experience in automation within a biopharmaceutical or pharmaceutical GMP environment
- Hands-on experience with Siemens Building Automation Systems (BAS)
- Strong experience with facility and utility automation systems
- Experience with PLC, HMI, and SCADA platforms
- Demonstrated experience writing and executing validation documentation including:
- Configuration Specifications (CS)
- Functional Risk Assessments (FRA)
- Automation Installation Qualification (AIQ)
- Automation Operational Qualification (AOQ)
- Requirements Traceability Matrix (RTM)
- Qualification Summary Reports (QASR)
- Understanding of the capital project lifecycle from design through CQV
- Experience working with instrumentation, process equipment, and control panels
- Ability to read P&IDs, electrical schematics, and automation logic diagrams
- Strong troubleshooting and problem-solving skills
- Excellent communication and stakeholder coordination skills
Preferred Experience
- Experience supporting facility and clean utility systems in pharma manufacturing
- Exposure to automation for purified water distribution systems
- Experience working on capital expansion or facility upgrade projects
- Experience collaborating with CQV teams and validation groups