Automation CQV Engineer

Seeking a seasoned Automation CQV Engineer to support commissioning, qualification, and validation of automation systems in API pharmaceutical manufacturing environments. This role requires hands-on experience with PLC/SCADA systems, strong working knowledge of Rockwell and/or Siemens platforms, and a deep understanding of GMP compliance and validation protocols. The successful candidate will contribute to major capital projects and be embedded at client sites to ensure systems are installed, tested, and validated according to regulatory and technical requirements.

Minimum Qualifications:

Bachelor’s degree in Engineering, Automation, Electrical, or related technical discipline.

10–20+ years of hands-on experience in commissioning and qualification of PLC/SCADA systems in operational pharmaceutical environments.

Demonstrated experience working with Rockwell Automation and/or Siemens PCS 7 control systems.

Proven track record of leading FATs, SATs, commissioning, and start-up of automation systems and process equipment.

Deep understanding of CSV, GMP validation lifecycle, and regulatory expectations in the life sciences sector.

Preferred Qualifications:

Experience with qualification management tools such as HP ALM (e.g., HPLM, eTIMS).

Strong familiarity with API manufacturing operations, equipment, and automation interfaces.

Industry Experience Required:

Pharmaceutical manufacturing (specifically API facilities).

Automation system testing and validation in GMP environments.

Platforms: Rockwell Automation, Siemens (PCS 7 or equivalent).