Process Microbiologist Sterile (18 month contract)
Merck Sharp & Dohme Corp.
Cork, IE
11d ago

Process Microbiologist Sterile (18 month contract) Job

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Enter your email to apply Requisition ID : MAN005475

MSD is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products.

The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where MSD has codified its 125-

year legacy. MSD’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.

MSD Manufacturing Division, MMD, is a team of dedicated, energetic individuals who are committed to being the most trusted supplier of pharmaceuticals and health products worldwide.

Our facilities, along with our external contractors, suppliers, and partners, comprise an interdependent global manufacturing network that’s committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe.

The Process Microbiologist will provide technical aseptic processing and microbial process support expertise to the sterile Integrated Process Team (IPT) in accordance with our priorities of : Compliance, Supply, Strategy and Profit Plan.

The working style is one of collaboration, coaching and facilitation to provide technical solutions to the IPT team to support a High Performance Organisation.

The Process Microbiologist will be an active member within the cross functional IPT Leadership Team providing support, guidance and striving for aseptic excellence to ensure the success of the IPT.

Primary activities / responsibilities :

  • Provide ongoing coaching and support to the IPT team members, to share their aseptic technical knowledge and promote best practices.
  • Education and communication of personnel in aseptic techniques, GMP requirements and regulations, specifically the requirements of Annex 1
  • Microbiology representative on sterile network teams
  • Member of facility design and control teams, in areas such as HVAC design and application
  • Collaborates in the development and execution of the facility-based environmental monitoring programs.
  • Process microbiology representative for facility and equipment qualification requirements
  • Provides aseptic guidance on facility and process-related controls and changes.
  • Handling of non-conforming EM / PM results, trend analysis
  • Troubleshooting of suspected microbiological contamination incidents
  • Participation in internal and external audits
  • Responsible for the preparation, review and approval of relevant technical documentation, risk assessments, CAPA's etc.
  • Ensure the highest quality, compliance and safety standards.
  • Participate and comply with our Quality Management System (QMS) requirements, including ownership, as relevant.
  • The Process Microbiologist is accountable for Environmental governance and support of the Aseptic process to deliver an effective and efficient IPT.

    Qualifications

  • Degree in Science / Quality and minimum of 5 years Operations / Quality Control Microbiology experience in a pharmaceutical environment
  • Working knowledge of regulatory expectations of Aseptic processing in the pharmaceutical industry. Specifically the requirements on Annex 1
  • Evidence of Continuous Professional Development. Working knowledge of regulatory expectations of Aseptic processing in the pharmaceutical industry
  • Strong analytical and technical skills.
  • Demonstrated high level of problem solving and facilitation skills resolution and prevention measures.
  • Highly motivated and interested in bringing current microbiology research and technology platforms toward aseptic operations application
  • Demonstrated self-motivation / direction skills with a continuous improvement focus
  • Demonstrated ability to lead and realise improvement initiatives
  • Demonstrated successes in a team environment, such as project teams, Six Sigma teams, CI teams etc
  • Advanced PC skills such as Excel, Word, Powerpoint
  • Focus on Customers, Including Patients

  • Focus the team on delivering value for customers, including patients, by understanding and meeting their needs.
  • Collaborate

  • Actively listen and seek to understand differing perspectives from project team members; work together to achieve the common goals of the company.
  • Act with Candor and Courage

  • Speak openly, honestly and with conviction; have the courage to take appropriate risks and make difficult decisions.
  • Make Rapid, Disciplined Decisions

  • Make timely decisions at the right level with the right data, document decisions and support them once made.
  • Drive Results

  • Set clear performance standards; overcome obstacles; hold ourselves and others accountable for achieving results.
  • Demonstrate Ethics & Integrity

  • Adhere to the highest standards of trustworthy and ethical behaviour in all interactions and hold others to the same standards;
  • comply with all laws, policies and regulations; identify and address ethical issues without hesitation.

    Build Talent :

  • Build diverse talent with the capabilities necessary to succeed in commercial sterile processing manufacture; inspire, Reward and develop to ensure individuals reach their potential;
  • make tough calls when necessary

    Your role at MSD is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement.

    At MSD, we’re inventing for life.

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