Setter

Company Overview

PCI Pharma Services specializes in bridging biopharmaceutical companies with life-changing therapies to impact patients globally. We invest in individuals who drive progress and innovation to shape the future of healthcare.

Work Schedule

The role entails working Thursday through Saturday during day shifts.

Key Responsibilities

• Consistently adhere to and promote safe working practices; promptly report any near-miss incidents to the Environmental Health and Safety (EHS) Department.
• Assist Operational Engineers in dismantling, cleaning, and reassembling production machinery according to scheduled maintenance protocols.
• Notify Operational Engineers of machinery or plant equipment needing significant repair or maintenance.
• Identify potential improvements within the production area concerning machinery or processes.
• Conduct packaging machine reel replacements, code updates, tooling changes, minor adjustments, and minor repairs.
• Operate in alignment with established Key Performance Indicators (KPIs).
• Support commissioning of tooling for new product lines.
• Maintain accurate engineering and Good Manufacturing Practice (GMP) records.
• Occasionally fulfill Operator responsibilities as needed.
• Prepare tooling for upcoming production batches.
• Engage actively in training initiatives.
• Maintain safe working conditions in compliance with safety, health, and environmental guidelines in accordance with company procedures and relevant legislation, including the Health and Safety at Work Act 2005.
• Keep immediate workspaces tidy, secure, and compliant with GMP standards, including storage areas.
• Effectively communicate any issues related to product, components, documentation, or equipment performance that seem irregular or incorrect.
• Accurately complete documentation for packaging tasks and assist with queries from Quality Control (QC) or Quality Assurance (QA) teams as needed.
• Continuously improve job-related knowledge and seek further training, particularly alongside Operational Engineers.
• Understand team structure and supporting departments, and collaborate effectively within teams.
• Comprehend the role of Quality Control in in-process checks (IPCs) and be prepared to perform IPCs if properly trained.
• Interpret and fulfill targets, ensuring proper documentation completion.
• Execute comprehensive packaging machine changeovers that meet quality and efficiency standards set by engineering management, adhering strictly to safety and GMP requirements.
• Ensure machinery is used only with proper guarding and report any equipment needing major repairs or maintenance to the Engineering Team Lead.
• Lead continuous improvement efforts in processes and equipment within assigned areas in cooperation with Operations Department colleagues.
• Perform effective shift handovers, advising appropriate management chains, and actively participate in process changeovers.

Candidate Requirements

• Demonstrable experience as a Production Operator at PCI Pharma Services or related mechanical engineering experience.
• Strong understanding of health and safety best practices, including relevant legislation.
• Familiarity with continuous improvement methodologies, such as Lean Six Sigma (Yellow Belt or equivalent).
• Ability to perform well in busy environments and collaborate effectively within teams.
• Proficient in IT usage, numeracy, and literacy.
• Meticulous attention to detail and clear, concise communication skills.
• Logical and organized approach to tasks.
• Competence in interpreting and accurately completing operational documentation.
• Practical technical skills applicable to the role.
• Commitment to adhering to Standard Operating Procedures (SOPs), Health, Safety and Environmental regulations, General Data Protection Regulations (GDPR), Good Manufacturing Practices (GMP), and other regulatory guidelines.
• Proven ability to meet targets, manage multiple tasks efficiently, and deliver results consistently.
• Experience working within GMP or other regulated environments.

Preferred Qualifications

• Experience working with Lean Manufacturing principles and tools aimed at continuous improvement.

Additional Information

Employment equity is fundamental at PCI Pharma Services. The company is an Equal Opportunity and Affirmative Action employer, promoting inclusivity and fairness without discrimination based on race, color, religion, age, gender identity, sexual orientation, disability, veteran status, or any other protected characteristics. PCI is committed to fostering a workplace culture where every individual feels valued and supported.