Process Engineer
Process Engineer
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Job Description
Benefits at bioMerieux:
- Lowcost 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 $10000 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 ontime 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 crossfunctionally to ensure successful project implementation.
- Provide subject matter expertise (technical knowledge) when acting as departmental representation on crossfunctional 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; followup 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.
- B.S. in Engineering Chemical/Bioprocess Engineering or closely related field required
- 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.
- Selfdirected individual who can work with limited direction. Ability to reprioritize 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.
Employment Type
Full Time
