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If you want to leave your personal mark and be valued for who you are, Johnson & Johnson offers an unusual experience to professionals looking for an opportunity to work with hardworking people who share your real passion for caring, in an environment that empowers you to drive your own career.
Janssen Pharmaceuticals Sciences UC has been operating in Little Island in Cork since 1981. We manufacture bulk active pharmaceutical ingredients that are sold throughout the world, to other Janssen and third-party companies, where they are further processed into tablets, creams or injectable dosage forms.
The Aseptic Process Specialist is a member of the Operations Team with primary responsibility to produce Aseptic and Low Bioburden API. This position provides operational leadership to a team of Manufacturing Process Specialists (MPS). We encourage and support the identification and development of innovative operational solutions and multi-functional collaboration throughout the Johnson & Johnson Global API Small Molecule Network.
This role has a large degree of scope and autonomy to improve production performance and reliability to improve human health by improving the first manufacturing step in changing patients lives for the better.
Key Responsibilities :
- Provide Subject Matter Expert (SME) assistance for all manufacturing operations in the Low Bioburden and Aseptic processing Modules and ensure business, quality and compliance goals are met following the J&J Standard of Leadership behavior model.
- Drive strategy improvements related to the reduction of contamination risks and the improvement of microbiological hygiene through the promotion of continuous improvement and open communication.
- Supervise an MPS team to deliver the production schedule in a timely manner with due regard for safety and quality.
- Through supervision, mentoring and support, develop the MPS team to become experts on the processes, equipment, and relevant regulatory requirements applicable to low bioburden and aseptic manufacturing.
- Support manufacturing investigations, identify and implement appropriate CAPAs, troubleshoot technical issues and provide general technical service support for manufacturing facilities and marketed products.
- Actively lead and participate in Continuous Improvement processes within the Operations department and work with all other departments to identify cost and process improvements.
- Act as SME for Operations during HPRA, FDA and other regulatory inspections as well as internal audits.
- Participate in and lead various initiatives and cross-functional investigations together with the Senior Operations Manager (SOM).
- Deputize for the SOM as required.
Qualifications & Experience
- BSc in a scientific/technical field as required.
- Minimum of 5 years of experience within a pharmaceutical or GMP supervised Operations environment.
- Possesses a detailed knowledge and experience of Aseptic Manufacturing Processes.
- Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals.
- Experience as a plant/process microbiologist within a Life Sciences or Biopharmaceutical manufacturing environment.
- Business Excellence and Problem Solving skills Qualifications e.g. Six Sigma, Lean Green/Black Belt or Kepner-Tregoe analysis.
- Advanced degree (MS, MBA, PhD) preferred.
- Communication and Leadership skills.
- Working on own initiative to achieve both individual and team based targets
- Great team mate with strong focus on the customer
- Strong Business Insight
- Excellent time management skills with good multi-tasking ability
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.