Hay setter

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.

We are PCI.

Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.

Main purpose of role:
The primary purpose of the Setter is to perform machine set ups and changeovers to target times as required in line with production requirements. Working in accordance with the company’s Health & Safety rules and GMP guidelines.

Main responsibilities:

- The Setter is required to complete effective, whole line changeovers in compliance with health and safety, and GMP requirements.
- Carry out packaging machine reel changes, code changes, removal and replacement of tooling, minor adjustments and minor repairs.
- Support the Operational Engineers to strip down, clean and reassemble production equipment as per routine maintenance schedules.
- Maintaining records such as Machine service logs, JDE engineering entries and engineering documentation in general.
- Advise Operational Engineers of any machine or plant which requires major repair or maintenance.
- Highlight potential areas for improvement within production area regarding equipment or procedural changes.
- Working to Key Performance Indicators (KPI’s)
- Assisting with commissioning the tooling for new products
- Preparing tooling for next production run
- Taking an active role in training highlighted by Engineering Management.
- Work in a safe manner complying with safety, health and environmental standards in line with company procedures. Responsible to ensure compliance with the Health & Safety at Work Act (1974) and regulations made under that act which are relevant to site activities.
- Maintaining the immediate work area in a clean, tidy and safe condition at all times and ensuring that Engineering Department areas and equipment are kept in a clean, tidy and secure state (this includes storage areas). The Setter must work in a GMP compliant manner at all times.
- Ability to effectively communicate line issues regarding anything concerning product, component, documentation, and equipment performance which appears unusual or obviously incorrect.
- Has the ability to correctly complete documentation entries for the packaging job. In conjunction with the Line Leader the Setter should be able to assist in answering any QC/QA queries that may arise, and can enter accurately any appropriate data required on a Batch Packaging Record or Clinical Trials Method.
- Improve job knowledge and seek support for areas on which training is required. In particular, the Setter will be expected to spend extended periods training alongside the Operational Engineers.
- Understand: their team structure; that of the supporting departments; and working in a team.
- Understand Quality Control role and in process checks (IPCs). Has responsibility for the quality of outputs from machines. The Setter should be prepared to carry out IPCs if appropriately trained to do so.
- Understand and can interpret targets and how to complete appropriate documentation.
- Responsible for taking a leading role in the continuous improvement of the processes and equipment within their area of responsibility, working in conjunction with other members of the Operations Department.
- Take a role in performing effective shift handovers to be able to advise and discuss with appropriate chain of command. Understand, and participate as a key role, in process changeover.

Work Experience and Skills Required

Essential
- Proven relevant experience working as a Production Operator within PCI Pharma Services or other relevant experience e.g. mechanical engineering based experience
- Health and Safety good practice (including Health and Safety legislation)
- Knowledge of Continuous Improvement methodology (ie Lean Six Sigma - Yellow Belt)
- Ability to work well in busy conditions and to operate effectively within a team
- Good IT Skills
- Good numeracy and literacy skills
- Demonstrates attention to detail
- Clear and concise communication
- Ability to be logical and orderly
- Ability to be comfortable with the interpretation and completion of documentation
- Have practical technical ability

Qualifications:
Essential
- GCSE Grade C and above in English, Science and Mathematics (or equivalent)
- Lean Six Sigma - Yellow Belt (or similar)
- Certificate of competence NVQ1/NVQ2 in Engineering or Packaging Operations

Regulatory/Industry Responsibilities:
General
- The job holder is responsible for adhering to PCI Standard Operating Procedures (SOPs), Health, Safety and Environmental rules, General Data Protection Regulations (GDPR), Good Manufacturing Practices (GMP) and other regulatory guidelines.

Join us and be part of building the bridge between life changing therapies and patients.

Let’s talk future

Equal Employment Opportunity (EEO) Statement:

- PCI Pharma Services