An Aseptic Lead is required for the Albumin Filling Plant at GWWO.
This key role is responsible for driving excellence in aseptic manufacturing through expert training, coaching, and oversight of cleanroom behaviours, contamination control, and sterile techniques. Acting as a Subject Matter Expert (SME), the Aseptic Lead supports site-wide sterility assurance initiatives and ensures alignment with current regulatory standards including EU GMP Annex 1 (2023), Annex 15, and cGMP requirements.
The successful candidate will lead the design and execution of training programs, media fills, personnel qualification, and contamination control strategies, while maintaining a strong partnership with Quality, Validation, and Operations teams. The role also includes active participation in inspection readiness and continuous improvement initiatives, contributing to both operational efficiency and regulatory compliance.
In addition, the Aseptic Lead will oversee environmental monitoring and sanitation efforts, support audit and inspection preparedness, and represent the site in aseptic governance forums. This position offers a high-impact opportunity to shape aseptic standards, mentor operations personnel, and influence the long-term success of sterile product manufacturing in a dynamic, multi-product environment.
What you will be doing?
- 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.Coach and support team members in their training and development to ensure they receive the appropriate qualifications.Establish and maintain training programs based on current sterile standards, regulatory guidelines, and best practices.Review and ensure aseptic filling documentation (., 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.Support and lead investigations affecting safety, quality, or compliance; ensure timely implementation of effective CAPAs.Deliver hands-on training to new and current employees, verifying their competency and qualification for aseptic operations.Stay current with industry developments by attending relevant conferences (., 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.Foster a culture of continuous improvement through constructive feedback and coaching on aseptic processes.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.Assume leadership over other operational areas as required by evolving business needs.Develop and implement comprehensive training and requalification programs for isolator activities, gowning procedures for Grade C and D areas, and aseptic behaviours.Contribute to the site’s sterility assurance program by ensuring facility design, equipment, and processes align with aseptic standards.Represent the site in aseptic governance bodies and cross-functional projects to ensure regulatory and global compliance in aseptic processing and sterile product filling.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.Maintain up-to-date knowledge of regulatory requirements and best practices relating to sterile product manufacturing, facility design, contamination control, and data integrity.Review and maintain site procedures related to gowning, aseptic practices, and contamination control.Deliver training in alignment with the site’s sterility assurance program and quality initiatives.Ensure full compliance with all EHS standards, including the timely reporting of incidents and active contribution to a culture of continuous safety improvement.The role will also lead other aspects of operations if the business need arises.Who we are looking for;
Strong knowledge of sterile manufacturing processes, aseptic techniques, and contamination controlDeep understanding of regulatory compliance within cGMP manufacturing, including EudraLex Volume 4, Annex 1, and EU GMP guidelinesKnowledge of filling and aseptic practices, sterilisation techniques, GMP regulations, and quality operationsProficient in environmental and personnel monitoring programs and trend analysisDemonstrated leadership skills, with the ability to motivate, guide, train, coach, and develop individuals and teamsAbility to coach, mentor, and cross-train colleagues within core technical areasStrong decision-making skills with the confidence to challenge respectfully and professionallyExcellent verbal and written communication skills, with strong technical writing abilityProactive and collaborative approach; works effectively with cross-functional teams such as Manufacturing, Validation, Engineering, and QualityStrong interpersonal skills; capable of maintaining productive relationships across departments and levels.Facility start-up experience.Willingness to travel domestically and internationally, as needed.Qualifications
Leaving CertificatePrevious experience in the pharmaceutical or bioscience industryBachelor’s degree in microbiology or a related disciplineMinimum of 5 years operations experience in a sterile manufacturing environmentHands-on experience developing and maintaining training programmesProven ability to work in a high-paced, goal-driven organisation and consistently achieve targetsTrain-the-Trainer qualificationOur Benefits Include :
Highly competitive salaryGroup pension scheme - Contribution rates are (1.5% / 3% / 5% / 7%) and company will matchPrivate Medical Insurance for the employeeOngoing opportunities for career development in a rapidly expanding work environmentSuccession planning and internal promotionsEducation allowanceWellness activities - Social activities eg. Padel, Summer EventsWe 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
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