Warning
This job advert has expired and applications have closed.
Calibration, Maintenance & Validation Manager
| Posting date: | 29 August 2024 |
|---|---|
| Hours: | Full time |
| Closing date: | 15 September 2024 |
| Location: | SR5 3XB & NE11 0SD |
| Remote working: | On-site only |
| Company: | Helena Laboratories (UK) Ltd |
| Job type: | Permanent |
| Job reference: |
Summary
Helena Biosciences is a leading and well established medical diagnostic company, with an international reputation comprising two flagship business divisions that specialise in the design, manufacture and support of Clinical Electrophoresis and Haemostasis systems.
This vacancy is the opportunity to be part of a fast-paced, long-term project to lead improvements to current practices, and to ensure that Helena Biosciences Europe’s manufacturing is well maintained and in consistent compliance whilst also effectively managing routine & reactive maintenance, calibration & validation of production equipment, monitoring and measurement equipment & supporting equipment and systems across the two sites at Gateshead and Sunderland.
The candidate would be a highly motivated and self-reliant person with a minimum of 5 years of experience and background in the medical device industry.
Calibration, Maintenance and Validation Manager
Main Duties and Responsibilities:
1. To manage the Manufacturing & Monitoring and Measurement assets and supporting facilities across the two manufacturing sites in Gateshead and Sunderland.
2. To preventively and reactively maintain various Manufacturing Equipment and Supporting Equipment where necessary, sometimes in-house, and self-maintained and sometimes externally through effective management of maintenance contracts for external activities that are necessary.
3. To maintain various Laboratory Analysers preventively and reactively for use in QC and Assay across the Gateshead and Sunderland sites.
4. To conduct reactive and preventive maintenance where necessary in-house.
5. To manage and conduct calibration activities pertaining to production, QC & assay processes, such as thermometry, balances, pipettes, gauges, measurement vessels and other monitoring and measurement equipment as necessary.
6. To take a leading role in improvements and modernisations with respect to asset management, preventive maintenance, reactive maintenance, calibration, service, and contract management.
7. To manage two DI water treatment plants across the Gateshead and Sunderland sites, to ensure that the quality of water entering products being produced from a gel base is fit for purpose and safe to use.
8. To centralise asset management of manufacturing equipment, monitoring and measurement equipment and supporting facilities.
9. To manage the production equipment and process validations across the Gateshead and Sunderland sites, ensuring that equipment and processes that are not verifiable in their output are validated for use prior to use in production processes.
10. To review the current processes and practices undertaken by Helena Biosciences Europe, and to create a new asset management plan accordingly.
11. To take a leading role in modernisation of production practices, including in various projects to secure manufacturing productivity, quality, and efficiency.
Key Skills Required
1. Extensive knowledge and experience of service, maintenance, and calibration
2. Extensive knowledge of electrical, electronic & mechanical principles
3. Knowledge of validation processes and protocols
4. Knowledge and experience of asset management
5. Knowledge of Good Manufacturing Practices (GMP)
6. Excellent fault-finding and troubleshooting skills
7. Experience of the preparation of standard operating procedures, and other pertinent documentation.
8. Extensive non-conformity investigation skills.
9. Clear attention to detail with regards to existing and new documentation.
10. Confident decision maker
11. Competent in the use of Internet, Microsoft, Windows programs including Word, Excel, PowerPoint, and other software solutions pertinent to the role (electronic QMS software, IMS software)
12. Able to communicate effectively to all personnel within the company
13. High levels of professionalism
14. Excellent delivery of training skills
Experience Required
1. A minimum 5 years of experience and background in the medical device industry
2. A minimum 5 years of experience in calibration, service, and maintenance related field
Qualifications Required
1. Degree level qualification in a relevant Scientific/Engineering field or equivalent experience
This vacancy is permanent, full time Monday to Friday (daytime hours) and based across both sites at Gateshead and Sunderland.
Salary: Competitive Remuneration Package (negotiable depending upon skills and experience)
Applications (including your current CV and covering letter) should be
e-mailed to personnel@helena-biosciences.com
www.helena-biosciences.com
Registered in England: 1796207
This vacancy is the opportunity to be part of a fast-paced, long-term project to lead improvements to current practices, and to ensure that Helena Biosciences Europe’s manufacturing is well maintained and in consistent compliance whilst also effectively managing routine & reactive maintenance, calibration & validation of production equipment, monitoring and measurement equipment & supporting equipment and systems across the two sites at Gateshead and Sunderland.
The candidate would be a highly motivated and self-reliant person with a minimum of 5 years of experience and background in the medical device industry.
Calibration, Maintenance and Validation Manager
Main Duties and Responsibilities:
1. To manage the Manufacturing & Monitoring and Measurement assets and supporting facilities across the two manufacturing sites in Gateshead and Sunderland.
2. To preventively and reactively maintain various Manufacturing Equipment and Supporting Equipment where necessary, sometimes in-house, and self-maintained and sometimes externally through effective management of maintenance contracts for external activities that are necessary.
3. To maintain various Laboratory Analysers preventively and reactively for use in QC and Assay across the Gateshead and Sunderland sites.
4. To conduct reactive and preventive maintenance where necessary in-house.
5. To manage and conduct calibration activities pertaining to production, QC & assay processes, such as thermometry, balances, pipettes, gauges, measurement vessels and other monitoring and measurement equipment as necessary.
6. To take a leading role in improvements and modernisations with respect to asset management, preventive maintenance, reactive maintenance, calibration, service, and contract management.
7. To manage two DI water treatment plants across the Gateshead and Sunderland sites, to ensure that the quality of water entering products being produced from a gel base is fit for purpose and safe to use.
8. To centralise asset management of manufacturing equipment, monitoring and measurement equipment and supporting facilities.
9. To manage the production equipment and process validations across the Gateshead and Sunderland sites, ensuring that equipment and processes that are not verifiable in their output are validated for use prior to use in production processes.
10. To review the current processes and practices undertaken by Helena Biosciences Europe, and to create a new asset management plan accordingly.
11. To take a leading role in modernisation of production practices, including in various projects to secure manufacturing productivity, quality, and efficiency.
Key Skills Required
1. Extensive knowledge and experience of service, maintenance, and calibration
2. Extensive knowledge of electrical, electronic & mechanical principles
3. Knowledge of validation processes and protocols
4. Knowledge and experience of asset management
5. Knowledge of Good Manufacturing Practices (GMP)
6. Excellent fault-finding and troubleshooting skills
7. Experience of the preparation of standard operating procedures, and other pertinent documentation.
8. Extensive non-conformity investigation skills.
9. Clear attention to detail with regards to existing and new documentation.
10. Confident decision maker
11. Competent in the use of Internet, Microsoft, Windows programs including Word, Excel, PowerPoint, and other software solutions pertinent to the role (electronic QMS software, IMS software)
12. Able to communicate effectively to all personnel within the company
13. High levels of professionalism
14. Excellent delivery of training skills
Experience Required
1. A minimum 5 years of experience and background in the medical device industry
2. A minimum 5 years of experience in calibration, service, and maintenance related field
Qualifications Required
1. Degree level qualification in a relevant Scientific/Engineering field or equivalent experience
This vacancy is permanent, full time Monday to Friday (daytime hours) and based across both sites at Gateshead and Sunderland.
Salary: Competitive Remuneration Package (negotiable depending upon skills and experience)
Applications (including your current CV and covering letter) should be
e-mailed to personnel@helena-biosciences.com
www.helena-biosciences.com
Registered in England: 1796207