Sterility Assurance Scientist - Ireland - Johnson & Johnson

Description

Job Description - Sterility Assurance Scientist W)

Sterility Assurance Scientist W

Description

Description

The Sterility Assurance Scientist is responsible to support the end-to-end implementation of contamination control and sterility assurance policies for the manufacturing of commercial products within Global Orthopedics. The defined make organizations include Cork, Ireland, as well as supporting defined suppliers. The Sterility Assurance Scientist will support in the areas of aseptic processing, contamination control, sterilization, reprocessing and microbiology. He/she will support product manufacturing activities.

This individual will be responsible for activities such as, but not limited to, the following: · R&D –
o provide technical support in the validation of aseptic manufacturing and sterilization methodologies
o support contamination control and sterility assurance requirement in the integration of acquisitions and new product licensing
o provide support in the development of design history files and regulatory submissions to ensure compliance to applicable regulations and standards internationally
· Plan –
o provide support in the development of new manufacturing operations (to include manufacturing sites and facility investments, contract sterilization & laboratories, and third-party manufacturers)
· Source –
o provide support in due diligence for sterile, non-sterile or microbiologically controlled manufactured products, and provide technical SME support for integration into J&J
o provide technical SME support for procurement activities that relate to sterile, nonsterile or microbiologically controlled products that are externally manufactured
o support requirements for new manufacturing processes, controlled environments and packaging from a microbiological, terminal sterilization and reprocessing
o provide support in the design of critical water and air systems and the design of controlled environments and cleanliness control strategies
o provide technical SME support for sterility assurance and contamination control in supplier audits.
· Make –
o support cross-functional compliance to the end-to-end sterility assurance policies at defined manufacturing facilities in Cork, Ireland
o ensure process changes meet contamination control and sterility assurance requirements
o support the investigation, gap analysis and develop the corrective action plan for microbiological or contamination control CAPAs and non-conformances, including root cause identification and corrective action implantation within agreed timelines
o supports technical assessments of third party manufacturers, sterilization contractors, external laboratories and other applicable suppliers.
o provide technical support during onsite inspections o work with internal and external laboratories to support sterility assurance testing requirements.
o work with the local Sterilization Execution organization to support the release of sterile product, and addressing any issues that might arise during the execution of the sterilization processes
· Deliver –
o support the ongoing initiatives regarding the validation of primary non-sterile and sterile packaging systems that meet the needs of distribution system and delivery of sterile or microbiologically controlled product to the patient and/or consumer
· External Influencing –
o develop knowledge on best practices in sterility assurance and contamination control by interacting with JJSA leadership.
· Internal Influencing –
o interacts with product development teams to ensure objectives and project timelines meet business needs. Interacts with their peers in sterility assurance to utilize resources and ensure best practices across facilities.
o participate on the J&J Sterility Assurance Councils

The Sterility Assurance Scientist technical areas supported include: aseptic processing, cleaning and disinfection requirements, sterilization validation (for EO, gamma, electron beam, moist heat, and dry heat processes), reprocessing, 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.

Qualifications

Job Qualifications:

1) 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
2) demonstrated competency in multiple healthcare and industrial terminal sterilization methods (e.g., EO, gamma, electron beam, moist heat, dry heat) is required
3) proven track record on troubleshooting process non-conformances and out of specification test results, and providing resolution to issues by a robust CAPA process
4) experience in interacting with Regulatory Authorities is preferred
5) experience with conducting technical assessments of in-house and external manufacturing and terminal sterilization is preferred
6) knowledge of standards including EU, USA and ISO is required
7) excellent oral and written skills and able to communicate both up and down the business ladder within franchise or technical competency area is required
8) demonstrated ability to work in a collaborative/teamwork environment is required
9) independent organizational and time management skills is required

Required Education and Experience:
1) an undergraduate (BS) degree with Microbiology, Biology, Engineering or related discipline is required; an advanced degree is desirable.
2) a minimum of 3 years of experience in a medical device or pharmaceutical (combination) industry with a GMP and/or ISO regulated environment is required.
3) competent in using computer software such as Excel, Word and PowerPoint, and analytical software.

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

Manager 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 Primary Location

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive considerationfor employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin,or protected veteran status and will not be discriminated against on the basis of disability.andEqual Employment Opportunity Posters GINA Supplement.

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