Microbiologist

Posted:
9/23/2024, 2:36:47 AM

Location(s):
Gurugram, Haryana, India ⋅ Haryana, India

Experience Level(s):
Junior ⋅ Mid Level ⋅ Senior

Field(s):
Product

Work Flexibility: Onsite

Who we want

  • Detail-oriented process improvers. Critical thinkers who naturally see opportunities to develop and optimize work processes – finding ways to simplify, standardize and automate. 

  • Strategic thinkers. People who enjoy analyzing data or trends for the purposes of planning, forecasting, advising, budgeting, reporting, or sales opportunities. 

  • Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions.

  • Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues. 

  • Dedicated achievers. People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations. 

What you will do:

Roles and Responsibilities

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

  • Be the point of contact for suppliers/development engineers for new process development, quality issues and process improvements for assigned projects.

  • Participate in the development and improvement of the manufacturing processes for existing and new products.

  • Support product transfers to other plants/facilities. 

  • Review/approve nonconforming material and system documentation.

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

  • Actively participate on teams to support new product development activities.

  • 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.

  • Implement data analysis and statistical techniques to drive appropriate risk management activities and prioritization of issues.    

  • Ensure effective implementation and compliance to all applicable regulations and standards, including 21CFR820, ISO 13485, ISO 14971 throughout the design and development process.

What you need:

Education:

M.Sc. in Microbiology

Experience: Min 3-6 years of experience in applied device or pharmaceutical microbiological or biological testing, research and development, or sterility assurance experience.

  • Demonstrated organizational and written/verbal communication skills.

  • Demonstrated ability to self-motivate

  • Demonstrated ability to effectively work with others in various coordinate disciplines and on multi-national teams.

  • Demonstrated ability to prioritize tasks in a deadline-driven environment.

Specific Job Skills:

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

  • Demonstrated knowledge about a variety of microbiological concepts, practices, and procedures.

  • Ability to use ISO, AAMI, USP, ANSI, EPA, EU and related guidelines toward the design, manufacturing, development, and launch of initiatives.

  • Experience with ISO 17025, Lab Quality Management System.

  • Ability to effectively work cross-functionally with Product Development, Operations and Marketing.

  • Must be results oriented, a quick learner, team player and able to respond to the urgent needs of the team ensuring all deadlines are met.

  • Demonstrated ability to technically mentor associate engineers and scientists.

  • Must understand the fundamentals of moist heat, gamma irradiation, and ethylene oxide sterilization.

  • Prefer experience with medical device product development lifecycle, including risk management and design/process verification and validation.

  • Experience in working in a compliance risk situation.

  • Demonstrated experience with bio-compatibility tests, ability to interpret the associated industry guidelines.

  • Prefer demonstrated competency in advanced testing technologies.

Travel Percentage: 20%