What are the responsibilities and job description for the Associate Process Engineer position at bioMérieux?
Position Summary & Responsibilities:
As part of the Industrialization department, the Associate Process Engineer will develop and/or manage process improvement projects to support the manufacturing of in vitro diagnostics. Within this role the Associate Process Engineer will be required to interface with Manufacturing, Quality Control, Quality Assurance, R&D, Purchasing, Supply Chain, HSE, and other functions as required, to ensure successful project achievements and to facilitate quality production that meets on-time customer demands. Duties will be carried 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.
- 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.
Education, Skills, & Experience:
- Bachelor's degree with 0 years of experience required. Degree in Chemical/Bioprocess Engineering or Biomedical Engineering are preferred.
- Associate's degree with 2 years of experience in a regulated industry or High School Diploma/GED with 4 years of experience in a regulated industry also accepted
- Experience related to data management and analysis is highly desired
- Experience in an FDA regulated industry is a plus
- 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.
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