Setter

About PCI Pharma Services

PCI Pharma Services is dedicated to delivering life-changing therapies with global impact. We collaborate with thousands of biopharma companies to bridge innovative medicines to patients worldwide. Our strength lies in investing in people who drive meaningful progress and pioneer the future of pharmaceutical manufacturing.

Shift Details

This role operates on a Thursday-Saturday day shift schedule.

Role Responsibilities

• Consistently enforce safe working methods and promptly report any near-miss incidents to the Environmental Health and Safety (EHS) department.
• Assist Operational Engineers in dismantling, cleaning, and reassembling production machinery as per scheduled maintenance routines.
• Notify Operational Engineers about any equipment or plant requiring significant repairs or maintenance.
• Identify and highlight opportunities for process or equipment enhancement within the production area.
• Conduct packaging machine operations including reel changes, coding updates, tooling removal and replacement, minor adjustments, and repairs.
• Work in alignment with key performance indicators (KPIs) to meet operational goals.
• Support commissioning of tooling for new products and maintain engineering and GMP documentation accurately.
• Occasionally cover Operator roles as needed and prepare tooling for upcoming production runs.
• Actively participate in training programs to enhance knowledge and skills.
• Adhere strictly to safety, health, and environmental policies as per company guidelines and comply with the Health and Safety at Work Act 2005.
• Maintain cleanliness, order, and security in working areas and engineering departments in accordance with GMP standards.
• Communicate clearly regarding any unusual issues with product, components, documentation, or equipment performance.
• Complete packaging job documentation precisely and assist with QA/QC inquiries, entering accurate data on Batch Packaging Records or Clinical Trials Methods.
• Seek continuous improvement in job knowledge by engaging in training alongside Operational Engineers.
• Understand the team structure, quality control roles, and be prepared to perform in-process checks (IPCs) if trained.
• Execute full packaging line changeovers meeting quality and efficiency standards set by engineering management.
• Ensure equipment is used only with proper guarding and report any equipment needing major maintenance to Engineering Team Leads.
• Lead initiatives to improve processes and equipment, collaborating with Operations department members.
• Perform efficient shift handovers and actively participate in process changeovers maintaining open communication with the chain of command.

Essential Qualifications and Skills

• Demonstrated experience as a Production Operator within PCI Pharma Services or similar mechanical engineering roles.
• Strong understanding and application of Health and Safety practices, including relevant legislation.
• Familiarity with continuous improvement methodologies such as Lean Six Sigma (Yellow Belt preferred).
• Ability to work under busy conditions effectively within a team environment.
• Competent IT skills and good literacy and numeracy abilities.
• High attention to detail, clear communication skills, logical thinking, and proficiency in interpreting and completing documentation.
• Practical technical aptitude.
• Commitment to following SOPs, GDPR, GMP, and other regulatory standards.
• Proven ability to deliver results, set clear goals, prioritize tasks, and manage multiple responsibilities.
• Experience working in GMP or regulated environments.

Desirable Attributes

• Experience with Lean Manufacturing and application of Lean tools for continuous process improvement.

Equal Opportunity Statement

PCI Pharma Services is committed to equitable employment practices and fosters an inclusive workplace free from unlawful discrimination based on race, color, religion, age, gender, nationality, disability, veteran status, or other protected characteristics. We strive to cultivate fairness, respect, and equal opportunity ensuring a workplace where every individual can belong and grow.