Pharmaceutical Technical Engineering Lead
London, Greater London, England
EC2V 8AF
- Pay
- £ 47154.0 - 52936.0 Per year
- Hours
- Full time
- Type
- Permanent
- Job level
- Qualified (non-manager)
- Posted
- 14 Jun 2022
- Closes
- 14 Jul 2022
Job Description
The core duties and responsibilities of this role are categorised under the following categories (please see attached job description for full details):
Technical/Operational
- To be conversant with water for injection (WFI) and steam production systems and associated sterilisation equipment.
- To oversee the continued compliant running of the Grade D and C Air Handling Units (AHU) performing routine maintenance and supervising more invasive maintenance / replacement activities.
- To be responsible for the performance of the critical utility systems (water, steam, air) and pharmaceutical manufacturing process equipment by ensuring routine field checks, trend analysis and data reporting is completed in a timely manner.
- To be responsible for the efficient operation of the pharmaceutical manufacturing equipment including the ROTA ampoule filling machine and the RIVA tabletting machine, including routine engineering set up, engineering troubleshooting and supervision of external contractors undertaking any maintenance.
- To prepare, review and comment as a pharmaceutical engineering expert on routine monitoring reports, planned preventative maintenance reports and undertake trend analysis of any reported data for all critical systems and equipment used in the manufacturing unit including presentation to senior management.
- To provide subject matter expertise both in engineering governance and good manufacturing practice for regulatory compliance and industry expectations with regard to pharmaceutical manufacturing processes.
Calibration / Validation
- To provide subject matter expertise on the validation and calibration requirements of the critical pharmaceutical systems, process equipment, plant and engineering systems.
- To be responsible for the routine validation of all GMP critical systems within the manufacturing facility including generation of an annual maintenance plan published in advance of the upcoming financial year and available to all production and quality teams.
- To be responsible for coordinating calibration activities of all GMP critical instruments in the PMU in accordance with current GMP guidelines, MHRA requirements and ISO/relevant standards.
- To be responsible for ensuring that all critical utilities and process equipment remain in a validated state at all times.
- To be responsible for the planning and oversight of validation and calibration activities carried out by external contractors for any test work that cannot be performed in-house
- To be responsible for the timely resolution of non-conformances and implement remedial actions/follow up work resulting from validation and calibration activity.
- To be responsible for authoring and where required, approval of validation protocols and procedures to carry out routine validation work in line with current GMP guidelines and MHRA requirements.
Quality Management
- To be responsible for maintenance of the Engineering quality system in conjunction with the quality lead for engineering.
- To undertake Quality deviation and Datix reporting in line with Departmental and Trust policies.
- To assist with investigation and CAPA implementation resulting from quality deviations arising from critical utility systems and any pharmaceutical equipment.
- To be responsible for maintaining Standard operating Procedures relating to all engineering activities and the site critical systems, manufacturing process equipment, plant and engineering systems.
Staff Management
- To be responsible for generation and continual update of the engineering team staff training programme ensuring that all engineering staff are skilled in working with the plant, critical systems and manufacturing machinery onsite.
- To ensure that engineering staff working in the production area are trained and competency assessed in the tasks they undertake and to review continued competence on an ongoing basis.
Person specification
Education / Qualifications
Essential criteria
- A HND or HNC in an engineering relevant subject or equivalent specialist experience, coupled with occupational training.
- Accredited specialist knowledge acquired through post graduate courses to be able to fulfil requirements of an Authorised Person role under the various engineering codes of practice.
Desirable criteria
- Masters degree in relevant engineering subject.
- NEBOSH Qualified
Previous experience
Essential criteria
- Demonstrated ability to manage and lead a team
- Portfolio demonstrating experience of working within a broad range of occupational guidelines
- Demonstrated ability to manage and operate computerised building and facility management systems
- Demonstrated understanding
Ref: LIS6736
Pharmaceutical Technical Engineering Lead
London, Greater London, Englandd Guy's and St Thomas NHS Foundation Trust- Pay
- £ 47154.0 - 52936.0 Per year
- Job level
- Qualified (non-manager)
- Hours
- Full time
- Posted
- 14 Jun 2022
- Type
- Permanent
- Closes
- 14 Jul 2022
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This job was posted to Pharmaceutical in London, Greater London, England
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