Job Description
Our client is a leading global pharmaceutical leader in innovation. The Director, Sterility Assurance is responsible for assuring that the companies programs are aligned with the overall Sterility Assurance Engineering programs.
Responsibilities of Director, Sterility Assurance:
- Serve as the global technical leader in the areas of sterilization, aseptic processing and microbiology with responsibility for all company sites.
- Have responsibility for defining company policy and developing company strategies with respect to cleanliness, sterilization, clean rooms, pure water systems and related areas.
- Work with the organization to establish long-range sterilization strategies for all the company products.
- Have managerial responsibility for the company Sterility Assurance functions. This individual will need to actively network with the internal and external scientific, technical and regulatory community to maintain state of the art knowledge.
- Support new product development, collaborating with Product Development and suppliers to provide design inputs as well as to validate sterile and microbiologically controlled products.
- Work with Supply Chain to establish, validate and maintain clean manufacturing environments, processes and utilities.
- Responsible for compliance to applicable Quality Regulations, ISO and AAMI standards, and other regional standards.
- Provide input in the design of manufacturing processes, controlled environments and packaging from a microbiological standpoint.
- Provide input for the design of water systems and controlled environments and cleanliness control strategies.
- Interact with external regulators and various levels of company management, working across many functional areas.
- Influence the company’s strategic and tactical direction and financial results globally through the application of technical leadership, knowledge and expertise.
- A high-level knowledge of standards including AAMI and ISO.
- The capability of representing the company at industry and standards associations, influencing regulations and standards.
- Excellent oral and written skills and ability to communicate both up and down the business ladder within franchise or technical competency area.
- A demonstrated ability to work in a collaborative, team oriented environment.
- Independent organizational and time management skills.
Technical Responsibilities of Director, Sterility Assurance:
- Sterilization validation (for EO, gamma, electron beam, moist heat, and dry heat processes)
- Microbiological testing to support the validation and maintenance of the sterilization processes and product label claims (e.g., bioburden, tests of sterility, BET)
- Environmental control and monitoring
- Reusable device reprocessing and water systems validation
- Sterility Assurance Engineering support to new product development and launch
- Compliance to applicable regulations and standards in the subject areas of Sterility Assurance Engineering and laboratories
- Inspection and submission support and health based risk assessment.
Requirements for Director, Sterility Assurance:
- Bachelor’s Degree with Microbiology, Biology, Engineering or related discipline is required. Advanced Degree (MS or PhD) is preferred.
- 15+ years of experience in a medical device or pharmaceutical, combination products industry with a GMP and/or ISO regulated environment.
- 10+ years of direct people management experience.
- Proficient computer software such as Excel, Word and PowerPoint, and analytical software.
- Experience in microbiology, sterilization validation (terminal, aseptic, and/or reprocessing) and environmental controls for a medical device or pharmaceutical manufacturing facility.
- A demonstrated competency in multiple industrial terminal sterilization methods (e.g., EO, gamma, electron beam, moist heat, dry heat).
- Understanding of the sterilization process, microbiological lethality as it relates to both product design and sterilization processing.
- Competency in additional technical areas such as reprocessing and microbiology laboratory operations experience is desired.
- Demonstrated capability to lead and train a diverse, multinational community of practice with multiple stakeholders, working in a supervisory, coaching, mentoring and/or influencing capacity.
- Experience in interacting with Regulatory Authorities.
- Experience with conducting technical assessments of in-house and contract sterilization processes or contract microbiological laboratories is preferred.
- A proven track record on trouble shooting microbiological and/or sterilization process non-conformances and out of specification test results and providing resolution to issues via robust CAPA.
NOTE: The new appointee will work closely alongside colleagues at the companies US plant, before transitioning to the company facility in Ireland.
For further details, please contact Larry on +353 1-2302400 / larry@rftgroup.ie
The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors. www.rftgroup.ie
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