Associate Principal Process Engineer

8 Minutes ago • 4 Years +
Software Development & Engineering

Job Description

The Associate Principal Process Engineer will lead the Reagent Engineering team for Sensor Manufacturing, ensuring optimal line performance, driving cross-functional troubleshooting, and collaborating on long-term process optimization. Key responsibilities include monitoring area performance, communicating issues to management, leveraging data for efficiency, managing documentation, leading validation protocols, participating in root cause analysis, and assisting in training.
Good To Have:
  • Project Management experience is preferred.
  • Knowledge of FDA/ISO regulations and equipment validation is preferred.
Must Have:
  • Act as lead point of contact within Engineering for Sensor manufacturing.
  • Lead communication of ongoing issues to management and drive resolutions.
  • Leverage data to enhance efficiency, reduce waste, minimize cost, and enhance safety.
  • Manage and develop engineering and compliance documentation, lead validation protocols.
  • Participate in cross-functional teams for root cause analysis and quality event investigations.
  • Assist in developing and administering training on new processes, procedures, and equipment.
  • Work with Project / Materials Engineering on long-term strategies for improvements.
  • High School Diploma and 10+ years of experience (or equivalent degree/experience).
  • Ability to collaborate professionally in a cross-functional team environment.
  • Strong knowledge of Microsoft Office (Word, Excel, PowerPoint, and Outlook).
  • Strong communication, interpersonal, analytical, and problem-solving skills.

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Description

The Associate Principal Process Engineer will work within the Reagent Engineering team as the lead point of contact for Sensor Manufacturing. Overall, this engineer will ensure day to day line performance is optimal, drive communication and cross functional troubleshooting / problem solving as needed, and work with Project / Materials Engineering in the development and execution of long term process optimization.

PRIMARY DUTIES

  • Main accountability is to act as the lead point of contact within Engineering for Sensor, working with manufacturing, line maintenance, and quality personnel to monitor and optimize area performance.
  • Lead the communication of ongoing issues to the management team and assist in driving to resolutions through the use of cross functional support, providing equipment expertise as needed routing troubleshooting.
  • Leverage data to assess equipment, personnel and material interactions with the area of ownership in order to enhance efficiency, reduce waste, minimize cost, and enhance safety.
  • Assist in the management and development of engineering and compliance related documentation throughout the equipment lifecycle / change control process, acting as lead for the execution of validation protocols attributed to area of ownership.
  • Participate in cross functional teams to drive root cause analysis and quality event investigations, as well as corrective actions and preventative measures attributed to area of ownership.
  • Assist in the development and administration of training and guidance to manufacturing, line maintenance, and quality on new processes, procedures and equipment to ensure successful implementation and operation.
  • Work with Project / Materials Engineering in the development of long-term strategies for equipment and process improvements.

POSITION REQUIREMENTS

  • High School Diploma and 10+ years of experience with mechanical troubleshooting, diagnostics, data analysis and/or validation
  • Technical Certification / Associates Degree and 8+ years of experience with mechanical troubleshooting, diagnostics, data analysis and/or validation
  • Bachelors Degree and 6+ years of experience with mechanical troubleshooting, diagnostics, data analysis and/or validation
  • Masters Degree and 4+ years oexperience with mechanical troubleshooting, diagnostics, data analysis and/or validation
  • Project Management experience is preferred.
  • Ability to collaborate professionally in a cross-functional team environment.
  • Knowledge of FDA/ISO regulations and equipment validation is preferred.
  • Strong Knowledge of Microsoft Office (Word, Excel, PowerPoint, and Outlook).
  • Must have strong communication and interpersonal skills.
  • Must have strong analytical and problem-solving skills.

WORKING CONDITIONS

Laboratory with exposure to chemicals

PHYSICAL REQUIREMENTS

Extensive standing, repetitive hand and arm motions, ability to climb steps.

Lifting (up to 50Lbs) and moving containers of cartons, tubes, and printed materials.

Must be able to push a wheeled cage that can weigh up to 600 lbs fully loaded.

Operating within cool temperature and low humidity conditions within the production room. Constant noise is common due to the operation of the air-dry chamber, taping and pouching equipment.

Excellent personal hygiene required. Appropriate gowning requirements necessary for the production areas. Gloves are required to handle the product. Hairnet, clean room gowns and/or lab coats are required. Safety glasses and hearing protection are required personal protective gear.

Occasional environmental odors may be prevalent.

Please be aware that recruitment related scams are on the rise. Fraudulent job postings are being placed on other websites, and individuals posing as bioMérieux Talent Acquisition team members are reaching out via email or text message in an attempt to collect your personal and confidential information. In some cases, these scammers are also conducting bogus interviews prior to extending fraudulent offers of employment. Beware of individuals reaching out using general phone numbers and non-bioMerieux email domains (i.e. Hotmail.com, Gmail.com, Yahoo.com, etc.). If you are concerned that an interview experience or offer of employment might be a scam, please make sure you are searching for the posting on our careers site https://careers.biomerieux.com/ or contact us at recruitment@biomerieux.com.

BioMérieux Inc. and its affiliates are Equal Opportunity/Affirmative Action Employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information. Please be advised that the receipt of satisfactory responses to reference requests and the provision of satisfactory proof of an applicant’s identity and legal authorization to work in the United States are required of all new hires. Any misrepresentation, falsification, or material omission may result in the failure to receive an offer, the retraction of an offer, or if already hired, dismissal. If you are a qualified individual with a disability, you may request a reasonable accommodation in BioMérieux’s or its affiliates’ application process by contacting us via telephone at (385) 770-1132, by email at recruitment@biomerieux.com, or by dialing 711 for access to Telecommunications Relay Services (TRS).

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