Provide process/equipment engineering support to the ongoing requirements of the Drug Substance Operating Unit
The process/equipment engineer is responsible for providing engineering and equipment qualification support to the operating unit ensuring that the equipment is running as intended and that all equipment issues are resolved to support the manufacture and timely disposition of product.
This role focuses on leading and resolving technical issues within the Operations Unit, implementation of CAPAs and process/equipment improvements, generation of product impact assessments, 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/ execution of assigned projects (short duration), which includes the management of internal company resources (assets financial and personnel), external Engineering and vendors as part of the execution of projects. The direct management responsibility includes all support activities and functions necessary to ensure successful completion of project objectives.
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 if required.
The Process/Equipment Engineer should have the ability to:
- 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.
- Provide technical and compliance review of testing protocols, reports and applicable manufacturing SOPs.
- Lead major process 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.
- APQR support regarding equipment/utility qualification and revalidation status & deviation trending
- Develop and Write structured Engineering memo's in support of investigation closures.
- 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 supplier and vendors.
- Identify equipment improvement and develop these into project scopes for Core Engineering/ Technical Services, this may also include progressing to funding approvals.
- Support Compliance Inspections and enquiries from Regulatory Agencies.
- Provide technical expertise during audits and also to present/ defend engineering systems, applicable change controls, investigations and equipment requalification packages to the regulatory agencies if required.
- Lead/ represent Technical Operations on short duration project teams where responsibilities would include upstream 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 and Core Engineering and Core Technical Services
Education & Experience
- Minimum qualification of a B. Sc. Degree in Engineering, Science or equivalent with particular emphasis in Biochemical, Chemical, Mechanical or Mechatronic discipline.
- A minimum of 5 Years cGMP industrial experience, ideally covering Operations, Engineering, Projects and equipment qualification within bioprocess manufacturing.
- In depth understanding of process/ equipment engineering including biotechnology, Bioreactor operation, aseptic techniques and harvest / centrifuge operations.
- Working knowledge of production operations, scheduling, design, planning, process evaluation, equipment selections calculations etc
- Ability to upgrade or direct technical aspects of equipment installation, start-up, troubleshooting and repair or to obtain appropriate outside repair services to accomplish same.
- Experience working with automated control systems, MCS (Manufacturing Control system) and PI (Data acquisition system).
- Demonstrated ability to provide technical solutions for complex problems through equipment/process knowledge.
- 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
- QTS training for events, commitments and change controls.
- Experience of FDA and EU licensing inspections.
- Experience or aptitude in leading and managing project work/teams.
- Experience of equipment commissioning, qualification and requalification.
- Certification to six sigma green belt would be an advantage.
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.
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