Identification de l’offre d’emploi R-416714 Date d’affichage 10/24/2021 Retour aux résultats de recherche Postuler

Process/Validation Engineer

Job Description Summary

The Process/Validation Engineer is responsible for establishing and coordinating all process & validation activities for the manufacturing operations at BDZ - Dymax.
PRIMARY DUTIES & RESPONSIBILITIES:
- Responsible for designing and developing processes to optimize process flow, reduce variability, improve operating capabilities, and ensure operator safety.
- Identify need for validation of manufacturing equipment/process and support systems to meet product requirements, regulations, quality and company policies.
- Lead the validation/qualification effort for equipment and processes (IQ, OQ & PQ).
- Perform and/or coordinate the development of required validation protocols, the execution of the validation and close-out of validation reports.
- Troubleshoot process, quality and safety issues, and make recommendations to mitigate problems.
- Responsible for maintaining the Validation Master Plan for BDZ - Dymax.
- Continuously evaluate information related to the overall performance of manufacturing processes/equipment.
- Make recommendations to changes in BDZ - Dymax QMS to ensure compliance with FDA Regulations & company policies.

Job Description

Be part of something bigger!

BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. We have over 65,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues.

The Process/Validation Engineer is responsible for establishing and coordinating all process & validation activities for the manufacturing operations at BDZ - Dymax.

PRIMARY DUTIES & RESPONSIBILITIES:

  • Responsible for designing and developing processes to optimize process flow, reduce variability, improve operating capabilities, and ensure operator safety.

  • Identify need for validation of manufacturing equipment/process and support systems to meet product requirements, regulations, quality and company policies.

  • Lead the validation/qualification effort for equipment and processes (IQ, OQ & PQ).

  • Perform and/or coordinate the development of required validation protocols, the execution of the validation and close-out of validation reports.

  • Troubleshoot process, quality and safety issues, and make recommendations to mitigate problems.

  • Responsible for maintaining the Validation Master Plan for BDZ - Dymax.

  • Continuously evaluate information related to the overall performance of manufacturing processes/equipment.

  • Make recommendations to changes in BDZ - Dymax QMS to ensure compliance with FDA Regulations & company policies.

Qualifications

Education

  • Bachelor's degree in Engineering.

  • Excellent written/oral skills.

  • Computer knowledge and its application to Quality and to Production process preferably.

Experience

  • Position requires a minimum of 8 years’ experience in Engineering in the manufacturing environment (electro-mechanical assembly). 

  • Lean manufacturing

  • Process design & validation

  • Equipment validation

Supervision

  • This position reports directly to the Engineering Manager.  Has no supervision of others.

Click on Apply if this sounds like you!

Why join us?

A career at BD means being part of a team that values your opinions and contributions and that empowers you to bring your authentic self to work. Here our associates can fulfill their life’s purpose through the work that they do every day.

You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. Our Total Rewards program — which includes competitive pay, benefits, continuous learning, recognition, career growth, and life balance components — is designed to support the varying needs of our diverse and global associates.

To learn more about BD visit https://jobs.bd.com/

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

Primary Work Location

USA PA - Zelienople

Additional Locations

Work Shift

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Lieu de l’emploi

Zelienople

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Lieu de l’emploi

Zelienople

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«Nous sommes une entreprise qui vise des résultats concrets et où nos associés s’emploient chaque jour à améliorer les soins de santé. De nombreuses initiatives sont en cours pour faire de BD un leader mondial des technologies médicales.»
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