Sterile Operations Manager

Wallace Myers International; Munster; In loco; EUR 70.000 - 110.000; Tempo pieno

Vantaggi offerti da questo lavoro

Health & safety

Employee training

Descrizione del lavoro

Wallace Myers International in Waterford, Ireland, is recruiting a Sterile Operations Manager for a Global Biopharma client. The role sits within Lyophilisation Operations and reports to the Lyophilisation OPS Head, ensuring reliable supply of lyophilised vial products for rare diseases worldwide.

You will lead batch filling and lyophilisation activities, drive continuous improvement, ensure cGMP compliance, oversee training, and partner with cross-functional teams to optimise performance and

Competenze

• Higher level Diploma/Degree in a third-level qualification or equivalent.
• Significant experience as an Operations Manager or other management role.
• Experience in a pharmaceutical manufacturing environment.
• Technical knowledge of sterile filling and lyophilisation technology.
• Detailed knowledge of cGMP regulations.
• Strong problem-solving and analytical skills.
• Effective facilitator with excellent interpersonal skills.
• Influences site KPI's and drives area improvement.
• Full understanding of Health & Safety and legal requirements for safe operation.

Mansioni

• Lead all operations activities including batch filling and Lyophilisation, managing batch turnaround time, release cycles, annual planning, CI plans.
• Ensure activities comply with cGMP (FDA 21 CFR Part 211, EU GMP Annex 1) and safety standards.
• Train employees on SOPs and GMP requirements relevant to their job.
• Ensure procedures are defined and followed.
• Monitor GMP compliance via audits, deviations and document reviews.
• Develop and improve training programs regularly.
• Develop and lead a continuous improvement program to reduce COGS.

Conoscenze

Operations mgmt

Pharma manufacturing

Sterile filling

Lyophilisation

cGMP

Problem solving

Interpersonal skills

Health & safety

Formazione

Higher level Diploma/Degree

Descrizione del lavoro

Jenn at Wallace Myers is recruiting a STERILE OPERATIONS MANAGER for our Global Biopharma client in Waterford.

MANUFACTURING OPERATIONS MANAGER - LYOPHILISATION

• Location: Waterford, Ireland
• Job Type: Permanent, Full-time
• Work Arrangement: On-site

About the role

Reporting directly to the Head of Lyophilisation Operations, you will play an integral role within the Lyophilisation Autonomous Production Unit management team, ensuring reliable supply of lyophilised vial products for our rare disease patients globally.

In Manufacturing & Supply, you'll help reimagine how life-changing treatments reach people everywhere, faster.

Join an AI-powered biopharma company committed to improving people's lives and delivering compelling growth.

Main responsibilities

• Lead all assigned operations activities to ensure that objectives are met; batch filling & Lyophilisation (Loading/unloading), batch turnaround time, batch release cycle time, annual planning, project/program implementation, CI plans, etc
• Ensure all activities are undertaken in compliance with cGMP (FDA 21 CFR Part 211, EU GMP Annex 1) and Safety standards
• Ensure all employees, for which they are responsible, are trained against SOPs and GMP requirements relevant to their job
• Ensure procedures are correctly defined and followed.
• Monitor the level of GMP compliance in their area on an on-going basis through audit, deviations and GMP document reviews
• Develop and improve the effectiveness of training on a regular basis
• Develop and lead a continuous improvement program that will result in savings to COGs

About You

• Higher level Diploma/Degree in Third level qualification or equivalent
• Significant experience as an Operations Manager/ other Management role
• Significant experience of pharmaceutical manufacturing environment
• Technical knowledge of relevant sterile filling and lyophilisation technology
• Detailed knowledge of cGMP regulations
• Good problem solving and analytical skills
• Effective facilitator & Excellent interpersonal skills
• Influences site KPI's and drives area improvement
• Full understanding of Health & Safety and legal requirements for the safe operation of his team

Why choose us?

• Shape the future of medicine and vaccine delivery with cutting-edge technology, ensuring seamless launches and a resilient global supply.
• Transform lives worldwide by delivering life-changing treatments anywhere, anytime.
• Grow, thrive, and make an impact in a workplace that empowers you to bring your best self every day, with pride.
• Help deliver 30 new product launches by 2030, ensuring patients get treatments faster than ever.

All applications will be treated with the strictest of confidence