Quality , Science, Pharmaceutical & Food
- Cork, County Cork, Ireland
PE Global is currently recruiting for a Process Microbiologist on behalf of our client based in Cork.
Full Time 12 Month Contract
For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric 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 means “You Belong”!
Reporting into the Plant Microbiologist the Technical Process 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 and change controls
- Perform routine area walkdowns. Support and drive process improvements related to the reduction of contamination risks and the improvement of microbiological practices.
- Foster and promote a contamination awareness culture through open and inclusive communication
- Perform and support Risk Assessments for operations projects and business innovation initiatives
- Regular review of key performance indicators of the contamination control program Provide effective and timely communication of any emerging trends, as appropriate
- Design and deliver training to support the site contamination control program
- Support and consult from a micro control perspective on capital project initiatives
- Maintain customer focus to deliver business requirements
- Collaborate with Operations Process Microbiologists (internal and at platform level), wider Operations team and cross functionally to achieve business goals
- Participate in the planning for future requirements in Operations
- 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
- BSc in a scientific / technical discipline required
- Minimum of 5 years of experience within a pharmaceutical or GMP regulated Operations environment
- Biomanufacturing possess knowledge and experience of shop floor manufacturing process is highly desirable
- Working knowledge of data analytics
- Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals.
- Experience as a manufacturing process specialist / 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
Interested candidates should submit an updated CV.
Please click the link below to apply, call Audrey on 0214297900 or alternatively send an up-to-date CV to firstname.lastname@example.org
***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***