Senior Automation CQV Engineer

Join our team as a Senior Automation CQV Engineer and play a key role in the commissioning, qualification, and validation of automation systems in pharmaceutical API manufacturing environments. We are looking for a candidate with extensive hands-on experience with PLC/SCADA systems, particularly Rockwell and/or Siemens platforms. A strong understanding of GMP compliance and validation protocols is essential as you will be instrumental in ensuring systems are installed, tested, and validated to meet regulatory and technical requirements on major capital projects.

Key Responsibilities:

Provide expertise in the commissioning and qualification processes for automation systems.

Lead Factory Acceptance Tests (FATs), Site Acceptance Tests (SATs), commissioning, and start-up of automation systems.

Collaborate with clients to ensure compliance with regulatory standards.

Engage in hands-on troubleshooting and problem-solving of automation systems.

Minimum Qualifications:

Bachelor's degree in Engineering, Automation, Electrical, or a related technical field.

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

Expertise in Rockwell Automation and/or Siemens PCS 7 control systems.

Strong foundation in 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).

Familiarity with API manufacturing operations and related automation interfaces.

Industry Experience Required:

Pharmaceutical manufacturing, specifically in API facilities.

Experience in automation system testing and validation within GMP environments.

Knowledge of platforms: Rockwell Automation, Siemens (PCS 7 or equivalent).