Sterile Operations Leader - Lyophilisation & GMP

Wallace Myers International; Munster; On-site; EUR 70,000 - 110,000; Full time

Benefits offered by this job

Health & safety

Employee training

Job summary

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

Qualifications

• 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.

Responsibilities

• 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.

Skills

Operations mgmt

Pharma manufacturing

Sterile filling

Lyophilisation

cGMP

Problem solving

Interpersonal skills

Health & safety

Education

Higher level Diploma/Degree

Job description

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