At Grifols, we believe that diversity adds value to our business, our teams, and our culture. We are committed to equal employment opportunities that foster an inclusive environment.

POSITION SUMMARY:

What will you be doing?

General:

Act as a knowledgeable Subject Matter Expert (SME) for aseptic filling operations within the Albumin plant.
• Provide cross-functional technical support and development to the aseptic filling operations team.
• Mentor and develop supervisors to become SMEs in aseptic techniques and behaviours, offering continued technical guidance.
• Lead the site sterility assurance program, including contamination control strategy (CCS), cleanroom design oversight, aseptic process simulation (APS/media fills), and environmental monitoring (EM).
• Offer expert input on sterile standards and guidelines, including Annex 1 (2023), Annex 15, and the EU GMP Guide.
• Ensure departmental objectives are achieved in alignment with company standards, with a focus on compliance, safety, and reliability.
• Design, update, and monitor training plans covering aseptic filling techniques and behaviours, tracking individual progress.
• Establish and maintain training programs based on current sterile standards, regulatory guidelines, and best practices.
• Review and ensure aseptic filling documentation (e.g., SOPs, OJTs) is accurate, up to date, and clearly written.
• Participate in and support process simulation (media fill) activities.
• Collaborate with Quality, Validation, and Operations teams to ensure successful execution of media fills.
• Stay current with industry developments by attending relevant conferences (e.g., HPRA, FDA) as required.
• Promote a safe working environment by complying with all Environmental, Health, and Safety (EHS) regulations and procedures.
• Generate reports and presentations as needed to support operational goals and project updates.
• Maintain oversight and awareness of ongoing activities in your assigned area of responsibility.
• Lead or support the execution of the personnel environmental monitoring (EM) plan for the filling department.
• Analyse trends in personnel and environmental monitoring data and implement corrective actions to enhance compliance.
• Provide both formal and informal feedback on the aseptic qualifications and performance of the operations team.
• Contribute to cleanroom operations and contamination control, ensuring adherence to current Good Manufacturing Practices (cGMP).
• Provide support for inspection readiness, including participation in health authority inspections, inspector interactions, and follow-up on observations.
• Lead audit preparedness efforts, ensuring facilities and equipment are inspection-ready and maintained to regulatory and corporate standards.
• Contribute to the site’s sterility assurance program by ensuring facility design, equipment, and processes align with aseptic standards.
• Oversee and support sanitisation programs across the facility.
• Assist in managing environmental monitoring (EM) and utilities programs, along with aseptic and contamination control strategies in a multi-product environment.
• Review and maintain site procedures related to gowning, aseptic practices, and contamination control.
• Ensure full compliance with all EHS standards, including the timely reporting of incidents and active contribution to a culture of continuous safety improvement.

Leadership and Managerial:

• The role will also lead other aspects of operations if the business need arises

• Deliver training in alignment with the site’s sterility assurance program and quality initiatives.

• Develop and implement comprehensive training and requalification programs for isolator activities, gowning procedures for Grade C and D areas, and aseptic behaviours.

• Foster a culture of continuous improvement through constructive feedback and coaching on aseptic processes.

• Assume leadership over other operational areas as required by evolving business needs.

• Deliver hands-on training to new and current employees, verifying their competency and qualification for aseptic operations.

• Coach and support team members in their training and development to ensure they receive the appropriate qualifications.

Technical:

• Maintain up-to-date knowledge of regulatory requirements and best practices relating to sterile product manufacturing, facility design, contamination control, and data integrity.

• Represent the site in aseptic governance bodies and cross-functional projects to ensure regulatory and global compliance in aseptic processing and sterile product filling.

• Support and lead investigations affecting safety, quality, or compliance; ensure timely implementation of effective CAPAs.

Who you will be?

Essential

• Strong knowledge of sterile manufacturing processes, aseptic techniques, and contamination control
• Deep understanding of regulatory compliance within cGMP manufacturing, including EudraLex Volume 4, Annex 1, and EU GMP guidelines
• Knowledge of filling and aseptic practices, sterilisation techniques, GMP regulations, and quality operations
• Proficient in environmental and personnel monitoring programs and trend analysis
• Demonstrated leadership skills, with the ability to motivate, guide, train, coach, and develop individuals and teams
• Ability to coach, mentor, and cross-train colleagues within core technical areas
• Strong decision-making skills with the confidence to challenge respectfully and professionally
• Excellent verbal and written communication skills, with strong technical writing ability
• Proactive and collaborative approach; works effectively with cross-functional teams such as Manufacturing, Validation, Engineering, and Quality
• Strong interpersonal skills; capable of maintaining productive relationships across departments and levels.

Desirable

Facility start-up experience.
Willingness to travel domestically and internationally, as needed.

Our Benefits Include:

• Highly competitive salary
• Group pension scheme - Contribution rates are (1.5% / 3%/ 5%/ 7%) and company will match  
• Private Medical Insurance for the employee (Irish Life)
• Ongoing opportunities for career development in a rapidly expanding work environment
• Succession planning and internal promotions
• Education allowance
• Wellness activities - Social activities eg. Padel, Summer Events

We understand that self-doubt can hold talented individuals back from applying for opportunities. We encourage everyone who meets the qualifications to apply – we're excited to hear from you

#LI-FD1