QC Micro Manager

Berkley Group; Dublin; On-site; EUR 90,000 - 120,000; Full time

Job summary

Berkley Group is seeking a QC Micro Manager for its south Dublin site to oversee microbiology readiness activities as the site expands its manufacturing operations.

The role focuses on establishing people, processes and laboratory capabilities, working with QC, Quality, Manufacturing and Engineering to ensure microbiology requirements are planned and implemented in line with GMP standards.

Qualifications

• Bachelor's degree in a Science-related field is required.
• 6+ years of bio-pharmaceutical QC experience, or related Quality Control/GMP laboratory experience in pharma/medical devices.
• Experience in a regulated cGMP manufacturing and/or testing environment.

Responsibilities

• Support planning and implementation of QC Microbiology activities for site expansion.
• Lead and coordinate QC Microbiology readiness activities for future operations.
• Assist in development, review, and implementation of GMP documentation (procedures, protocols, reports).
• Support definition, procurement, qualification and implementation of microbiology lab equipment, consumables and media.
• Plan resource, training and qualification to prepare QC Microbiology personnel.
• Provide microbiology input into cross-functional project activities and represent QC Microbiology.
• Collaborate with Quality, Manufacturing, Engineering and others to integrate microbiology requirements into plans.
• Contribute to Environmental Monitoring and other microbiological testing programs as applicable.
• Supervise and coach QC Microbiology staff as required.

Skills

QC Microbiology

GMP compliance

Leadership

Project coordination

Education

Bachelor's degree in science

Job description

Global Biotechnology company based in south Dublin, Ireland - looking for QC Micro Manager.

The Manager will primarily operate on a day-based working pattern, with flexibility to transition to or support a 16/5 working pattern depending on business and operational needs.

The successful candidate will play a key role in supporting QC Microbiology readiness activities associated with the expansion of manufacturing operations at the site. The role will have a particular focus on establishing the people, processes, systems and laboratory capabilities required to support future operations.

The Manager QC Microbiology will work closely with QC, Quality, Manufacturing, Engineering and other cross-functional partners to ensure that microbiology requirements are appropriately planned, developed and implemented as the site expansion progresses.

The role:

• Support the planning and implementation of QC Microbiology activities associated with the expansion of manufacturing operations at the site.
• Lead and coordinate QC Microbiology readiness activities, ensuring appropriate planning and execution in advance of operational requirements.
• Support the development, review and implementation of GMP documentation, including procedures, protocols, reports and other controlled documentation required to establish and maintain QC Microbiology operations.
• Support the definition, procurement, qualification and implementation of microbiology laboratory equipment, consumables and media required to support future operations.
• Support resource, training and qualification planning to ensure QC Microbiology personnel are appropriately prepared for future operational requirements.
• Provide microbiology input into cross-functional project activities and represent QC Microbiology at relevant project and operational forums.
• Work closely with Quality, Manufacturing, Engineering and other stakeholders to ensure microbiological requirements are incorporated into project and operational planning.
• Support the establishment, implementation and maintenance of Environmental Monitoring and other microbiological testing programmes, as applicable.
• Supervise and/or manage QC Microbiology personnel as required and provide effective coaching, development and technical leadership.

Have You:

• Bachelor's degree in a Science-related field is required.
• 6+ years of bio-pharmaceutical QC experience, or related Quality Control/GMP laboratory experience within the pharmaceutical or medical device industry, is preferred.
• The successful candidate should have experience working within a regulated cGMP manufacturing and/or testing environment.
• Experience in one or more of the following areas would be particularly advantageous:
• Environmental Monitoring and microbiological control programmes.
• Aseptic manufacturing operations.
• Establishment or expansion of QC laboratory or manufacturing capabilities.
• Commissioning, qualification or validation activities.
• Implementation of new microbiological equipment, methods or processes.
• Development and implementation of GMP procedures and documentation.

The successful candidate must have eligible working VISA in Ireland or European Union (EU) passport.