Duties & Responsibilities
* Manage the specification, development, installation and validation of automation projects within budget and corporate guidelines.
* Lead and manage multiple concurrent automation system migration projects (e.g., PLC, SCADA, DCS, BMS, EMS, MES).
* Act as technical lead for defining migration strategies, timelines, resource plans, and risk assessments.
* Work with cross-functional teams to ensure minimal impact to manufacturing operations and compliance with GMP/21 CFR Part 11/Annex 11.
* Lead efforts in system architecture design, I/O migration, network reconfiguration, and system integration.
* Manage automation vendors and integrators, ensuring delivery meets technical and quality standards.
* Ensure validation and qualification activities are aligned with regulatory requirements (e.g., IQ, OQ, PQ documentation).
* Attend control system hardware and software FATs.
* Support change control processes, including documentation, implementation, and deviation handling.
* Mentor and provide technical guidance to junior engineers and automation support staff.
Required Qualifications and Experience:
* Bachelor's or Master's degree in Electrical Engineering, Automation, Mechatronics, Computer Science, or related field.
* Minimum 7+ years of experience in automation engineering, with at least 3 years in a senior or lead role in a regulated pharmaceutical or biotech environment.
* Proven experience leading control system migrations, ideally from platforms such as:
* Siemens S7 / PCS 7
* Rockwell Automation / Allen-Bradley
* Strong knowledge of GAMP 5, CSV, and data integrity principles.
* Understanding of ISA-95, ISA-88, and good software development practices.
* Excellent project management, stakeholder engagement, and documentation skills.
* Familiarity with industrial communication protocols (Profibus, Modbus, OPC UA, Ethernet/IP).
* Experience with Batch systems, MES integration, and historian systems (e.g., PI, FactoryTalk Historian) is a plus.
Preferred Certifications
* PMP or equivalent project management certification
* GAMP 5 training/certification
* Six Sigma or Lean Manufacturing exposure
* Vendor certifications (e.g., Rockwell, Siemens, Emerson)
Work Environment:
* Cleanroom and GMP-regulated production areas
* Interaction with global engineering teams and site leadership
* Participation in audits and regulatory inspections as SME
Reporting Line
* Reports to:
Client
Automation Manager / Engineering Lead
* Direct Reports: May include Automation Engineers or Technicians, depending on project scope.