Production Operator

About PSC Biotech

PSC Biotech is an established biotech consultancy founded in 1996, headquartered in Pomona, California, with operations across Ireland, India, Singapore, Australia, and the US. We serve over 350 clients in more than 23 countries, offering cloud-based quality management software, pharmaceutical contract manufacturing expertise, and metrology services.

Our Employee Value Proposition emphasizes working alongside talented professionals within the pharmaceutical and biotech industries, providing permanent employment contracts and exposure to top pharmaceutical clients in culturally diverse workplaces.

Role Overview

The Production Operator role is part of the Integrated Production Team (IPT), focusing on various production and operational duties to support the efficient manufacture and dependable supply of products. This position operates on a 24/7 shift basis onsite and requires adherence to compliance, safety standards, and customer supply reliability.

Key Responsibilities

• Operate and monitor production equipment and processes using MES/DCS and PLC systems, including parts washers, autoclaves, tank cleaning panels, vial washers, depyro tunnels, debaggers, and filling machines to maximize uptime and meet output targets.
• Perform clean room housekeeping and material handling, emphasizing continuous process enhancements based on Lean methodologies.
• Manage the flow and inventory of equipment, monitoring sterile and soiled hold times, labeling, and using Kanban and automated MES systems for QC status and expiry control.
• Conduct maintenance tasks including preventative maintenance and equipment troubleshooting where qualified.
• Participate in drafting and updating operational procedures and training materials; engage in investigations, change controls, Kaizen projects, and root cause analyses using tools like FMEA, Fishbone diagrams, and the 5 Whys methodology to resolve system issues.
• Ensure compliance with global policies, regulatory requirements, and current Good Manufacturing Practices (cGMP) in daily work and assigned functions.
• Collaborate to foster a safe and compliant workplace culture.
• Perform additional tasks as required.

Experience and Skills

• Familiarity with sterile filling equipment and processes.
• Understanding of regulatory and code requirements applicable to Irish, European, and international standards.
• Proficient report, policy, and standards writing capabilities.
• Competence in Microsoft Office and related job-specific software.
• Strong communication and interpersonal skills to work collaboratively within teams and with external clients.
• Ability to understand departmental functions and their relation to overall business processes.
• Customer service focus, self-motivation, adaptability, multi-tasking, and excellent attention to detail.
• Analytical and troubleshooting capabilities.
• Goal-oriented mindset with training abilities.

Leadership Attributes

• Customer and patient centricity.
• Collaborative approach.
• Honesty and courage in actions.
• Ability to make swift, disciplined decisions.
• Drive to achieve results.
• Talent development focus.
• Ethical conduct and integrity.

Education & Experience Requirements

• Minimum education: Leaving Certificate or equivalent is required.
• Preferred education: Apprenticeship, certificate, or diploma in a relevant field.
• Prior related experience is typically expected, ideally within a GMP manufacturing environment.