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Job Function:

Quality

Job Sub Function:

R&D/Scientific Quality

Job Category:

Professional

All Job Posting Locations:

Ringaskiddy, Cork, Ireland

Job Description:

Position: Senior Scientist

Title: Senior Scientist Sterility Assurance

Project Management

Global Orthopedics

Description

The Sterility Assurance Senior Scientist, Project Management is responsible to support the end-to-end implementation of strategic projects associated with contamination prevention and sterility assurance across the make/deliver and product development teams for Global Orthopedics and will support programs to be aligned with the overall J&J Sterility Assurance programs.

The Senior Scientist will serve as a technical support leader in the areas of aseptic processing, contamination control, sterilization, reprocessing and microbiology. He/she will support strategic and tactical projects across the network, including R&D and manufacturing organizations. This position is responsible for compliance to applicable Quality Regulations and standards.

This individual will be responsible for activities such as, but not limited to, the following:

R&D –
- Maintain central GO policy documents; update and ensure integration cross-franchise as directed.
- Support due diligence on contamination prevention and sterility assurance for acquisitions and new product licensing. Develop plans on integration post-acquisition of determine needs on divestiture.
- Drive innovation to provide novel methodologies, processes or strategies for contamination prevention and sterilization.
- Support research or investigatory studies

Plan –
- Provide support in the development and selection of new manufacturing operations (to include manufacturing sites and facility investments, contract sterilization & laboratories, and third-party manufacturers)

Source –
- Provide support in Business Unit/Franchise due diligence for sterile, non-sterile or microbiologically controlled manufactured products, and provide technical SME support for integration into J&J
- Provide technical SME support for procurement activities that relate to sterile, non-sterile or microbiologically controlled products that are externally manufactured
- Provide input in the design of new manufacturing processes, controlled environments and packaging from a microbiological, terminal sterilization and reprocessing standpoint
- Provide technical SME support for sterility assurance and contamination control in supplier audits.

Make –
- Support the alignment of central GO policy documents for contamination prevention and sterility assurance in accordance with franchise, corporate and applicable international standards; support the update of and ensure integration cross-franchise as required.
- Maintain knowledge of best practices, standards and guidance in sterilization, processing, aseptic technique and environmental monitoring.
- Support key supplier management and audits, including point of contact for define strategic collaborations
- Support opportunities for business continuity planning for sterilization and contamination prevention across GO

Deliver –
- Customer engagement and support, monitoring trends in Customer needs with feedback to Management

External Influencing –
- Monitors best practices in sterility assurance and contamination control by interacting with JJSA leadership.

Internal Influencing –
- Interacts with business leaders to ensure objectives and project prioritization meet business needs. Interacts with their peers in sterility assurance to utilize resources and ensure best practices across facilities.
- Participate on the J&J Sterility Assurance Councils

The Senior Scientist, Project Management technical areas overseen include: aseptic processing, cleaning and disinfection requirements, sterilization validation (for EO, gamma, X-Ray, moist heat, and dry heat processes), reprocessing, organizing microbiological testing to support the validation and maintenance of the sterilization processes and product label claims (e.g., bioburden, tests of sterility, endotoxin monitoring), environmental control and monitoring, water and air systems validation, compliance to applicable regulations and standards in the subject areas of sterility assurance and laboratories. Inspection and submission support and Health based risk assessment.

Job Qualifications:

Qualified candidates will have experience in microbiology, sterilization validation (terminal, aseptic, and/or reprocessing) and environmental controls for a medical device or pharmaceutical manufacturing facility.
Experience with licensing and acquisition support in microbiology/sterility assurance.
Competency in multiple healthcare and industrial terminal sterilization methods (e.g., EO, gamma, electron beam, moist heat, dry heat) is required.
Proven track record on troubleshooting process non-conformances and out of specification test results, and providing resolution to issues by a robust CAPA process.
Experience in interacting with Regulatory Authorities is preferred.
Experience with conducting technical assessments of in-house and external manufacturing and terminal sterilization is preferred.
Strong knowledge of standards including EU, USA and ISO is required.
Strong teamwork and communication skills to work effectively on cross-functional project teams, interacting with a diversity of disciplines such as R & D, Packaging Engineering, Quality Engineering, Regulatory Affairs, Marketing, etc.
Excellent oral and written skills and able to communicate both up and down the business ladder within franchise or technical competency area is required.
Demonstrated ability to work in a collaborative/teamwork environment is required independent organizational and time management skills is required.

Required Education and Experience:

An undergraduate (BS) degree with Microbiology, Biology, Engineering or related discipline is required; an advanced degree is desirable. a minimum of 5 years of experience in a medical device or pharmaceutical (combination) industry with a GMP and/or ISO regulated environment is required. competent in using computer software such as Excel, Word and PowerPoint, and analytical software.

Supervisor: This position will report into a Sterility Assurance Supervisor.

Work Environment: The work environment is primarily in a local office, and may require frequent interactions with manufacturing. The individual must be able to comply with established safety procedures and policies to maintain a safe working environment to ensure compliance with J&J environmental policies.

Primary Location: DePuy Synthes Manufacturing Site

Organization: Global Orthopedics

Travel: Yes, 10-20%

Job Function: Quality