Process Equipment Engineer

Serve as key technical role responsible for ensuring consistently high performance of manufacturing equipment and processes. The role requires strong focus on driving quality into production processes, implementation of best practices, and continuous improvement. The incumbent will provide focused process ownership and the technical expertise to ensure high quality and efficient sterile injectable products. As technical lead, the Process Equipment Engineer partners with supervision and production colleagues to identify and implement innovative solutions.

The Process Equipment Engineer is responsible for providing engineering and equipment qualification support to the operating units ensuring that the equipment is operating as intended and all equipment issues are resolved to support the manufacturing operations and timely disposition of product.

This role focuses on resolving technical and engineering issues, implementation of CAPAs and process/equipment improvements, providing routine technical support and trouble-shooting, investigation closeout and maintaining the qualification status of the physical plant and equipment.

The Process Equipment Engineer is responsible for project management and / or execution of assigned projects, which may include the coordination of internal company resources and vendors as part of the execution of projects. The Process Equipment Engineer is responsible for providing technical expertise during audits and also to present / defend engineering systems, applicable change controls, investigations and equipment qualification packages to the regulatory agencies as required.

• Ensure all equipment installed is safe, effective and in compliance with industry standards.
• Ensure all company and site engineering policies and procedures are adhered to.
• Act as assigned technical lead and owner of manufacturing equipment and process systems.
• Provide technical and compliance review of testing protocols and reports.
• Lead or support major equipment related investigations and implement equipment CAPA and performance improvements.
• Generate and execute documentation for cGMP validation, requalification and periodic review of systems, equipment & manufacturing processes, including validation plans, annual revalidation plans, risk assessments, IQ/OQ/PQ/QV protocols and reports to maintain the equipment in a validated state.
• Provide routine equipment technical support and troubleshooting for resolution of manufacturing issues.
• Provide technical training on process and equipment as required by Operations.
• Develop and maintain productive links with process equipment & technology suppliers and vendors.
• Provide technical expertise during audits and also to present/ defend engineering systems, applicable change controls, investigations and equipment requalification packages to the regulatory agencies as required.
• Lead / represent Engineering on project teams where responsibilities would include SME technical oversight and the management and resolution of technical issues or changes arising throughout the project lifecycle whilst ensuring overall project objectives of scope, cost and schedule are adhered to.
• Work to implement a culture of Right-First Time through partnerships with Operations, New Product Introduction teams and Technical Services.
• Lead Method 1 s to determine root cause and implement corrective actions.
• Develop and implement, and permanently resolve problems through root cause analysis.
• Partner with SPM principals, Quality, OpEx, and other internal experts to develop quality investigations, assign root cause, and identify/implement CAPA solutions.
• As an individual contributor, represent manufacturing on assigned to project teams to ensure completion of key projects initiatives.
• Lead technical improvement projects aimed at zero defects , equipment reliability, and maximized utilization.
• Anticipate potential process-related problems, risks, and technical conflicts and develop necessary contingency plans that optimize business continuity.
• Ensure work activities are conducted in strict accordance with safety guidelines and processing standards cGMP s and SOP s.

• Minimum qualification of a Degree in Engineering, Science or equivalent with particular emphasis on Process, Chemical or Mechanical disciplines.
• GMP industrial experience, ideally covering Engineering, Projects and equipment qualification in a regulated environment.
• Ability to direct technical aspects of equipment installation, start-up, troubleshooting and repair or to obtain appropriate outside repair services to accomplish same.
• Demonstrated ability to provide technical solutions for complex problems through equipment and process understanding.
• Proficient in the use of structured problem solving tools such as Process Mapping, RCA (Root cause analysis), FMEA's (Failure Mode effects analysis) etc.
• Excellent communication and interpersonal skills and an ability to work independently
• Prefer an understanding of Pharma / Bio-pharma process equipment and change management
• This job description indicates the general nature and level of work expected of the incumbent. It is not designed to cover or contain a comprehensive listing of all activities, duties or responsibilities required of the incumbent. Incumbents may be asked to perform other duties as required.

People / Values Non-People leaders

• Demonstrate the GC OWNIT values
• Adhere to all HR Policies as appropriate
• Personal Development plans focus on the 70:20:10 guidelines
• CI tools/- capability is a key building block for learning & development - Trained and M1 certified.
• Proactive engagement with key stakeholders.
• Best practices developed and shared with other teams /sites.
• Best practices actively sought and copied.

Proactive & effective communication within and across shifts 

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