Senior Engineer- Microbiologist

Who we want:

• Meticulous documenters. Detail-oriented people who enjoy maintaining meticulous documentation of reports, metrics, proposals, and presentations.

• Self-directed initiators. People who take ownership of their work , results -oriented, and need no prompting to drive productivity, change, and outcomes.

• Team-player s . People who can collaborat e globally and thrive when developing lasting interpersonal relationships.

What you will do:

• Lead new product development and /or changes to medical devices currently i n the market for sterilization .

• Support design verification and validation test requirements that ensure appropriate objective evidence is available to support acceptance criteria .

• Participate in design reviews by identifying risks associated with the product use and tracking how the design, documentation, and manufacturing process mitigate those issues throughout the development process.

• Lead/support NC and CAPA activities.

• Lead departmental initia tives including setting timelines and milestones.

• Review/approve product and process change control documentation and specifications.

• Support product transfers to other plants/facilities.

• Partner with cross functional teams including (RA, AO, Ops ) to ensure business unit project timelines are met .

• Partner with team by contribut ing to the development, maintenance , and improvements of the policies and procedures related to sterilization .

• May support in the development, review and approval of sterilization process and equipment validation/qualifications (IQ, OQ & PQ).

• Act as sterilization subject matter expert to align to best practices, benchmarking against industry leads and regulatory requirements.

• Lead root cause analysis, problem solving , and out-of-specification investigations.

• Define validation activities ( i. e. product adoptions, testing plans, etc. ) .

• T rain and guide team members junior to you and other functions in area of sterilization .

What we need :

Required:

• M. Sc. in Microbiology/Applied Microbiology/Biological Sciences or related discipline .

• 5 + years related experience, medical device, pharmaceutical or chemical industry .

Preferred:

• At least 2+ years of experience in medical device industry.

• Knowledge of GDP, ANSI, AAMI, ISO, FDA, and USP guidelines related to sterilization ( i. e. ISO 1 7665 , ISO 11137, ISO 11135, etc. ).

• Must understand the fundamentals of at least one of the following sterilization techniques: gamma irradiation, ethylene oxide (preferred), hydrogen peroxide, moist heat, or dry heat and be an expert in one of the techniques.

• D emonstrated ability to effective ly communicat e , manage projects, and influenc e as well as can prioritize and manage multiple tasks simultaneously.

• Ability and desire to work effectively in a fast-paced multi-disciplinary team environment.

• Strong interpersonal skills including strong written and oral communication. Strong in critical and analytical thinking .

• Highly developed problem-solving skills. Demonstrated ability to write technical documentation.

• Demonstrated ability to successfully manage and complete projects in a matrix organization. Demonstrated ability to work independently.