- Reference: 46496
- Job Type: Permanent
- Location: Connacht, Leinster, Westmeath
- Category: Science, Pharmaceutical & Food
Senior Director, Sterility Assurance Engineering
A fantastic opportunity to join a rapidly emerging Biopharma/ Biotech company based in the midlands. Our client is seeking to recruit a Senior Director, Sterility Assurance Engineering for their new site.
Duties and Responsibilities
The Senior Director, Sterility Assurance Engineering will:
- Serve as the global technical leader in the areas of sterilization, aseptic processing and microbiology.
- 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 company products.
- Have managerial responsibility for Company Sterility Assurance Engineering 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.
- 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.
- 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.
- An undergraduate (BS) degree with Microbiology, Biology, Engineering or related discipline is required; an advanced degree (MS or PhD) is preferred.
- A minimum of 12 years of experience in a medical device or pharmaceutical. (combination) industry with a GMP and/or ISO regulated environment.
- A minimum of 8 years of direct people management experience highly desired.
For a confidential discussion and more information on the role, please contact David Lennon on 09064 78104 and email your CV to email@example.com
For more information on our Recruitment and HR Services and to see a full list of our available jobs across Ireland, please visit our website www.collinsmcnicholas.ie