Manufacturing Shift Manager

3 weeks ago

Ballina, Mayo County, Ireland TEAM HORIZON Full time
Team Horizon is seeking a Manufacturing Shift Manager for our client based in Mayo. In this role you will lead and facilitate the safe operations of the 24/7 Biologics manufacturing team in a bio-pharmaceutical processing facility in line with all safety, regulatory and operational requirements.

This is a shift based role, you will be required to work 12-hour shifts between days and nights on a monthly rotation.

As part of your new and exciting role you will assure the long-term effectiveness of the team: deliver high levels of customer service, ensure quality of product and services, comply with all regulatory requirements, achieve desired financial performance including cost reductions, and build a culture of high performance for the team

Why you should apply:

This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses. There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve people's lives. Our client is developing the capability to produce all its medicines, helping to ensure continuity of supply of our medicines as they expand internationally.

What you will be doing:

Act as key point of technical contact for aseptic fill finish activities. Supervision and execution of compounding, filling, lyophilization, equipment preparation, formulation, buffer preparation and support processing activities in the biologics fill finish facility to meet clearly stated operating objectives You will lead, coach & mentor your manufacturing team, across a 12-hour rotating shift, to maximize the effectiveness through clear and effective communication of task details and goals to their team members, to allow the biologics technicians to work effectively As part of this diverse and inclusive team, you will conduct on the floor promotion of a culture of contamination control and compliance with aseptic best practice. Communicate the departmental goals, to provide cost effective quality compliant products in a safe, effective manner We believe in collaboration so in this role, you will liaise with program management, supply chain, technical operations quality and engineering groups to ensure effective planning, scheduling and execution of commercial and NPI clinical manufacturing Resolve operations/project issues by working with team members, project customers, and others as appropriate. Responsible for driving operations excellences and Key operations targets including OEE where applicable Provides direct interface as a subject matter expert with QA department to interaction with HPRA, FDA and applicable health authority and internal audits

What you need to apply:

Minimum of 3 year's experience in batch processing, automation, commissioning and validation in an FDA/HPRA regulated industry.  3rd level qualification in a Science, Engineering or related scientific field, advanced degree is preferred Detailed knowledge of cGMP and regulatory requirements relating to the pharmaceutical industry is required for this role. Comprehensive understanding of the principles of contamination control and regulatory expectations for aseptic processing.  Has a technical background in pharmaceutical, biologics, or similar industries  A minimum of 1 year team direct supervisory experience in a team environment Flexibility with working 12-hour shift, rotating between days and nights on a monthly rotation Possess a strong technical knowledge and application of concepts, practices, and procedures. Works on problems of complex scope where analysis of situations or data involves multiple competing factors. Exercises judgment and advises management as to the appropriate actions

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