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.

Shift: Thursday-Saturday day shift

Key Responsibilities

• Ensure safe work practices are being followed at all times, report any near misses immediately to the EHS Department.
• Support the Operational Engineers to strip down, clean and resemble production equipment as per routine maintenance schedules.
• 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.
• Carry out packaging machine reel changes, code changes, removal and replacement of tooling, minor adjustments and minor repairs.
• Working to Key Performance Indicators.
• Assisting with commissioning the tooling for new products.
• Maintaining Engineering and GMP records.
• Covering Operator’s role from time to time.
• Preparing tooling for next production run.
• Taking an active role in training.
• Work in a safe manner complying with safety, health and environmental standards in line with company procedures. Responsible to ensure with the Health and Safety at work Act 2005 and regulations made under the act which are relevant to site activities.
• Maintaining the immediate work area in a clean, tidy and safe condition at all times and ensuring the Engineering Department areas and equipment are kept clean, tidy and secure state (this includes storage areas). The Setter much work in a GMP compliant manner at all times.
• Ability to  effectively communicate line issue 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 Lead, 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: the team structure, tat of the supporting departments; and working in a team.
• Understand Quality Control role a in process checks (IPC’s). Has responsibility for the quality of outputs from machines.  The Setter should be prepared to carry out IPC’s if appropriately trained to do so.
• Understand and interpret targets and how to complete appropriate documentation.
• The Setter is required to carry out packaging machine reel changes, code changes, removal and replacement of tooling, minor adjustments, minor repairs and provisional set ups in compliance with Health & Safety and GMP requirements. Complete whole line changeovers that will then be of any quality to achieve an efficiency and effectiveness rate, which is of any acceptable standard by the engineering management.
• Ensure that no equipment is used without adequate and effective guarding and advising the Engineering Team Lead of any machine or plant that requires major repair or maintenance.
• 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.

Knowledge / Skills & Experience

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
• 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. 
• The essential duties and responsibilities listed above are not intended to be an exhaustive list of all responsibilities, duties and skills required.
• Carry out various other additional tasks that may be required from time to time in accordance with the overall goal of the company
• Proven track record of showing how results were delivered within role
• Capability to set clear goals, communicate these clearly and ensure progress to completion meeting predefined targets.
• Ability to manage multiple tasks and set priorities.
• Experience in a GMP or Regulated Environment.

Desirable:

• Experience in Lean Manufacturing, including experience in Lean tools to develop continuous improvements.

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 is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

At PCI, Equity and Inclusion are at the core of our company’s purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.