Senior Aseptic Process Specialist

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Job Description:

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.

You will be 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 to the Aseptic processing and low bioburden 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.
• Supervision of an MPS team to deliver the production schedule in a timely manner with due regard for safety and quality.
• Supports manufacturing investigations, troubleshoot technical issues and provide general technical service support for manufacturing facilities and marketed products.
• Actively participates in Continuous Improvement processes within the Operations department and works with all other departments to identify cost and process improvements.
• 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

Required:

• 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 and Annex 1 requirements.
• Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals.
  

Preferred:

• 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

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