Johnson & Johnson Careers
Scientist QC Microbiology
Requisition ID: 1805674581W
Role: Scientist, QC Microbiology
Location: Ringaskiddy Cork, Ireland
Reports to: Manager, QC Microbiology & IPC
Janssen Sciences Ireland UC established its operation in Ringaskiddy in 2005 on a 100-acre site with an investment of €500 million. For more than 25 years we have been a global leader in the field of biomedicines, particularly in groundbreaking monoclonal antibody technology, an approach to producing medicines that launched a new generation of products to treat immune related diseases such as rheumatoid arthritis and plaque psoriasis.
The facility in Ringaskiddy is fully operational and currently expanding its operations to continue focusing on producing biomedicines for both the treatment of immune related diseases and new and creative cancer treatments.
We have an exciting opportunity for a Scientist in QC Microbiology to join our team in Cork. This individual will be responsible for providing technical support & oversight to the QC Microbiology laboratory in addition to collaborating with Microbiology SME’s in both tactical and strategic initiatives across our global Janssen network.
What you’re great at:
• Strong Microbiology testing background including a good understanding of Biopharmaceutical manufacturing processes.
• Excellent collaboration & communication skills, both written and oral.
• Strong leadership and both stakeholder and project management experience.
• Advanced root cause problem solving and process optimization skills.
• Excellent team player with strong customer focus.
• Knowledgeable of FDA/EMEA regulatory requirements (Annex 1 & Annex 2 EU GMP).
As a Scientist, QC Microbiology, your typical day may include:
• Collaborating with Microbiology colleagues across the network while also supporting global Micro CoE initiatives and building a community of global Microbiology support resources as required.
• Deployment of rapid micro techniques & new emerging technologies that may be applied in QC.
• Developing efficient & compliant lab processes whilst also anticipating and planning for future requirements in QC Microbiology area.
• Providing strategic support to the development of laboratory automation structures (e.g. sample management, data handling & reporting).
• Providing internal & external technical troubleshooting of QC Microbiology testing methodologies and techniques.
• Collating and reviewing of QC related data used to support regulatory filings in addition to addressing any requests for information from health authorities.
• Completing & responding to regulatory commitments associated with QC Microbiology related areas.
• Generating site trends (utilities) whilst supporting the identification of appropriate corrective and preventative actions and providing QC representation on the Critical Utilities Team.
• Ensuring that our microbiological testing strategy is consistent with GMP requirements (Annex 1 & Annex 2 EU GMP) and company requirements as per Platform.
• Ensuring that the design and qualification of QC testing is performed according to GMP requirements.
• Ensuring that activities are carried out in compliance with cGMP and company quality standards. Understanding and supporting current regulatory trends and future testing requirements and participating in relevant internal and external QC related audits.
To be part of this high performing team you will have:
• An MSc or BSc in Microbiology or related Scientific discipline.
• 5+ years’ experience within a regulated biologics or pharma industry.
• Knowledge of FDA/EMA regulatory requirements.
• Excellent social and communication skills.
• Be self-driven and keeps up to date with regulatory, technical developments within the industry.
• Acute attention to detail.
• A focus on patients and customers at all times.
What we’re about:
We are passionate about our work and 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. We share a kind of DNA where we’re each:
• Committed to caring.
• Responsible to our communities.
• Ready to apply our knowledge and know-how.
• Rare in our background and experiences.
• The drivers of our own success.
• Passionate about doing what’s right.
Make a unique mark in your career
If you want to be seen for the talent you bring to your work, be the driver of your own career, and work with others who share your real passion for caring and success, then we invite you to join the Johnson & Johnson Talent Community by visiting www.careers.jnj.com
If you decide to apply for the position, any personal data which you provide shall be processed by Johnson & Johnson Medical, a Johnson & Johnson company. Your personal data shall be processed for the purposes of recruitment, recruitment policy and selection.
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
Janssen R&D Ireland (7566)