Manufacturing Operations Specialist

About PSC Biotech

PSC Biotech is a biotech consultancy established in 1996 and based in Pomona, California, USA. The company operates globally across Ireland, India, Singapore, Australia, and the United States, and supports 350 clients in more than 23 countries. Its services include cloud-based quality management and regulatory inspection software, support for pharmaceutical contract manufacturing professionals, and metrology services.

Role Overview

This opportunity is for a Manufacturing Operations Specialist to support process teams in a regulated pharmaceutical environment. The position is offered on a contract basis and is based on-site in Cork, County Cork, Ireland. The role is intended for someone who can contribute to operational delivery, quality compliance, and continuous improvement across commercial and clinical product activities.

What PSC Biotech Offers

PSC Biotech positions its employee value proposition around career growth, learning and development, in-house training, and mentorship. The organization highlights the chance to work with highly skilled peers in the pharma and biotech sector, as well as exposure to major pharmaceutical client sites in a multicultural setting. The company also emphasizes delivering high-quality work within budget and on schedule.

Key Responsibilities

The selected candidate will work closely with Process Team Leads and handle a mix of operational, quality, and improvement-focused duties. The work may involve commercial and clinical products such as small molecules, biologics, drug substance, drug product, and packaging operations.

• Support Process Team Leads with prioritized activities across commercial and clinical product operations.
• Carry out transactional ERP work for manufacturing and supply activities at CMOs, including production transactions, work order updates, purchase order receipting, and inter-organizational transfers.
• Take ownership of assigned change controls and deviations in the Quality Management System, ensuring timely closure without affecting supply.
• Compile and release performance metrics for each process team.
• Act as a cover resource for Process Team Leads when required, including during holidays.
• Contribute to continuous improvement projects aligned with site business goals and measurable savings in time and cost.
• Partner with cross-functional teams to investigate issues, perform root cause analysis, and implement corrective actions.
• Prepare business process documentation in a standard format such as a Best Practice Document or Standard Operating Procedure.
• Carry out operational tasks where needed to reduce or remove unnecessary handoffs and touchpoints.
• Remain flexible and adaptable as responsibilities may change with business priorities.

Experience and Qualifications

A minimum of 5 years of experience in operations within a regulated environment is required, along with a relevant third-level qualification.

Required Skills and Capabilities

The role calls for someone who understands ERP platforms such as SAP and is familiar with the unit operations and processes assigned to the team. Strong communication, initiative, drive, organization, and the ability to work independently are all important. The candidate should also be comfortable engaging cross-functional teams to resolve immediate issues and support long-term performance improvements. Experience using lean, Six Sigma, or other continuous improvement methods is also expected.

Additional Notes

This role is designed for a candidate who can work in a fast-moving regulated manufacturing environment and contribute to both daily operational support and broader efficiency improvements.