Benefits at bioMerieux:

• Low-cost medical, dental, and vision benefits starting day one
• 11 paid holidays
• 160 hours of paid time off
• Annual bonus
• 9.5% 401k company contribution with no vesting period
• Tuition reimbursement up to $10,000 per calendar year
• Onsite cafeteria with daily food stipend

Position Summary:

As part of the Industrialization department, the Process Engineer will support manufacturing operations by developing and/or managing process improvement projects to support the manufacturing of the manufacturing of in vitro diagnostics. Within this role the Process Engineer will be required to interface with Manufacturing, Quality Control, Quality Assurance, R&D, Purchasing, Supply Chain, JSE. and other functions as required, in order to ensure successful project achievements to facilitate quality production that meets on-time customer demands. Duties will be carries out as a member of a team committed to Total Quality Management philosophy. Work will be conducted in accordance with GMP and ISO rules and regulations.

Primary Responsibilities:

• Support and/or manage multiple projects related to the manufacturing of in vitro diagnostics.
• Guide timelines, adjust expectations, coordinate with colleagues, and collaborate cross-functionally to ensure successful project implementation.
• Provide subject matter expertise (technical knowledge) when acting as departmental representation on cross-functional teams, as well as, participate and identify improvement opportunities and strategies.
• Design and conduct statistically valid, scientifically sound feasibility studies and process development projects, and prepare timely written updates and report of these activities.
• Write and execute validation protocols as required by the change control and validation programs.
• Analyze process and product performance data to predict/prevent potential failures and aid in solving product/process challenges.
• Analyze components (materials) to mitigate manufacturing risk and/or cost saving initiatives.
• Support investigations and implementation of solutions (corrective and preventative actions) to solve manufacturing and product challenges; follow-up on actions to determine their effectiveness and suitability; and, prepare written reports on these activities in a timely fashion.
• Perform all work in compliance with company quality and safety procedures and standards.
• Performs other duties as assigned.

Knowledge, Skills, and Experience:

• Studies and Experience:
  • B.S. in Engineering, Chemical/Bioprocess Engineering, or closely related field required
    • Minimum B.S. with 3 years of experience, or M.S. with 1 years of experience.
  • Preferred: Experience in an FDA regulated industry.
• Skills and Qualifications:
  • Strong knowledge of cGMP practices along with understanding of formulation/filtration/filling.
  • Strong project management skills.
  • Experience with data analysis and statistical software competence, such as Minitab.
  • Experience in authoring and review/approval of documentation.
  • Experience with implementing changes through change control / qualification process.
  • Exhibit instrument, process, and/or method troubleshooting skills.
  • Self-directed individual who can work with limited direction. Ability to re-prioritize workload independently to address business needs.
  • Excellent organizational, analytical, and written/oral communication skills.
  • Ability to assess safety and environmental risks to ensure tasks adhere to HSE policies
  • Demonstrated ability to work in a team environment and communicate at all levels.

Job ID: 40191

Nearest Major Market: Durham
Nearest Secondary Market: Raleigh