Technical Process Specialist Operations
Contract: Full Time/Permanent
For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.
We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences
That is why we in Ireland are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are.
Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”!
Reporting into the Plant Microbiologist the Operations microbiologist is responsible for Active participation in the microbiological control and assurance program within the operations department. Managing activities in compliance with corporate, cGMP, EHS, and other regulatory requirements.
The responsibilities & the impact YOU will have:
- Lead by example and striving to perform to high standards at all times in compliance with Credo and Standards of leadership.
- Perform all activities in compliance with corporate, cGMP, EHS, and other regulatory requirements.
- Actively lead / support process microbiological investigations.
- Perform routine area walkdowns.
- Support and drive strategy improvements related to the reduction of contamination risks and the improvement of microbiological hygiene through the promotion of a culture of continuous improvement and open communication.
- Perform Risk Assessments for operations projects and business innovation initiatives
- Define specific aseptic techniques to be performed for crucial process steps
- Perform periodic review of environmental monitoring and in-process sampling trends and identifies appropriate corrective and preventative actions as required.
- Provide effective and timely communication of any adverse trends or activities as appropriate.
- Achieve goals through actively working with departments and individuals
- Maintain customer focus to deliver business requirements.
- Collaborate with Process Microbiologists internally and across the JnJ network
- Access global microbiology support resources, as required.
- Review and approve relevant SOP’s and WI’s.
- Participate in the planning for future requirements in Operations.
- Ensure microbiological control strategy is consistent with GMP requirements and company requirements.
- Participate in relevant internal and external manufacturing related audits.
- Understand and support current regulatory trends and future testing requirements.
- Deputize for Plant Microbiologist, as required
- Always comply with EHS rules and procedures.
- Travel to JSC, J&J and other external sites, as required, for meetings, training etc.
We would love to hear from YOU, if you have the following essential requirements:
- BSc in a scientific/technical discipline required.
- Minimum of 5 years of experience within a pharmaceutical or GMP regulated Operations environment.
- Possess knowledge and experience of the shop floor manufacturing process.
- Possess knowledge of data analytics
- 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.
This is what awaits YOU at J&J:
This is an opportunity to work with a groundbreaking biomedicine operation and to be a member of a Johnson & Johnson company, with an excellent record in employee continuous professional development and business improvement.
We are passionate about our work; we play vital roles across a range of professional disciplines and care deeply about our customers and communities. At Johnson & Johnson our culture enables dynamic and impactful careers.
Whether you’re one of the people who already work here, or you’re considering joining the team, we offer:
- An opportunity to be part of a global market leader.
- A dynamic and inspiring working environment.
- Opportunities to work on challenging projects and assignments.
- Possibilities for further personal and professional development/education
- Excellent Benefits