Job Description:
At Grifols, we are leaders in plasma-derived medicines and transfusion medicine, developing, producing, and marketing innovative medicines, solutions, and services in over 110 countries and regions. We believe that diversity adds value to our business, teams, and culture.
Main Responsibilities:
* As a knowledgeable subject matter expert (SME), perform tasks related to filling aseptic operations.
* Provide cross-functional development and technical expertise to the filling operations team in the aseptic Filling department in the Albumin plant.
* Develop supervisors to become subject matter experts in aseptic techniques and behaviors, continuing to provide technical support.
* Provide input and expertise on sterile standards, guidelines in Annex 1 2023, Annex 15, and EU GMP Guide.
* Ensure objectives are effectively achieved, consistent with company requirements, to ensure compliance, safety, and reliability.
* Create, revise, and monitor training plans for aseptic filling techniques, behaviors, and monitor the progress of each team member.
* Support/coach team members' training/development needs and ensure all receive appropriate training and qualification.
* Develop and maintain training programs focusing on sterile standards, guidelines, and regulations.
* Review aseptic filling documentation (SOP's, OJT's, etc.) for the area to ensure they are current, accurate, and clear.
* Be effectively involved in process simulation media fills.
* Liaise with Quality, Validation, and operations teams to ensure successful completion of process simulation media fills.
* Support investigations that impact safety, quality, and/or compliance of processes, ensuring investigations are carried out and actionable CAPAs are implemented within agreed timelines.
* Perform hands-on training of new and current team members while ensuring they are competent and qualified to perform their duties.
* Keep up-to-date with industry trends via conferences, HPRA, FDA, and attend when required.
* Support a safe working environment by complying with all pertinent environmental health and safety practices, rules, and regulations.
* Generate reports and presentations as required.
Requirements:
* Strong knowledge of sterile manufacturing processes.
* Experience with regulatory compliance in cGMP manufacturing and in-depth knowledge of EudraLex Volume 4, Annex 1 Manufacture of Sterile Medicinal Products, and Eu GMP guide.
* Knowledge of filling and aseptic practices, sterilization, GMP regulations, and quality operations.
* Strong knowledge of environmental monitoring, personnel monitoring, and contamination control.
* Demonstrated leadership skills with ability to motivate, guide, train, coach, and develop teams.
* Demonstrated ability to coach, mentor, and/or cross-train colleagues within core technical areas.
* Interacts well with diverse groups (manufacturing, validation, engineering, quality, etc.) and maintains strong working relationships with internal and external collaborators.
* Facility start-up experience is an advantage.
* Willingness to travel domestically and internationally if/as required.
Gowning Requirements:
* Gowning from one grade to another requires stepping over benches without assistance or support rails.
* When placing arms inside sleeves, individuals must stand unaided.
* Bending forward requires covering the head and body with gowns.
* Bending forward again requires zipping between both legs.
* Standing unaided or raising one leg to place boots on.
* Once inside the area for the role, standing for up to four hours at a time is required to monitor and train technicians.
Documentation Requirements:
* Time spent at a desk writing documentation can vary during a shift, potentially up to a full shift depending on accumulated documentation.
Qualifications:
* Previous pharmaceutical/bioscience experience.
* Bachelor's degree in microbiology or related discipline.
* Five years or more operations experience in a sterile manufacturing environment.
* Hands-on knowledge developing and maintaining training programs.
* Ability to motivate, guide, train, coach, and develop team members.
* Proactive and works well with others in a collaborative, fast-paced goal-driven environment.
* Proven ability to work in a high-paced organization and effectively reach targets and goals.
* Excellent decision-making skills and confidence to challenge others respectfully and professionally on decisions that impact the aseptic filling area.
* Excellent verbal and written communication skills, strong technical writing skills.
* Train-the-trainer qualified.
Benefits:
* Highly competitive salary.
* Group pension scheme - contribution rates are 5% employer and 5% employee.
* Private medical insurance for the employee.
* Ongoing opportunities for career development in a rapidly expanding work environment.
* Succession planning and internal promotions.
* Education allowance.
* Wellness activities - social activities eg. Golf, Padel, Summer Events.
About Us:
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.