
Production Process Specialist
hace 1 día
Job Description:
Labchems Corp. is seeking a highly skilled Production Process Specialist - Life Cycle Management to join our Engineering team.
About the Role:
This position will work closely with cross-functional teams to support design changes impacting operations, manufacturing, launch readiness, and production stability requirements of existing products.
The ideal candidate will provide technical expertise and project leadership in areas such as medical device life cycle management, supplier change management, cost of goods (COGs), process development, validation, and production stability.
Responsibilities include reviewing and updating applicable product specifications and drawings for legacy products, developing and issuing change control documentation to address changes in components and/or raw materials requested by suppliers following applicable procedures.
The successful candidate will also be responsible for supporting the selection and validation of replacement materials, such as polymers, metals, and adhesives, as well as manufacturing process improvements.
Requirements:
- Bachelor's degree in Engineering (Mechanical, Industrial, Electrical, Chemical, Biomedical) or sciences.
- Professional Engineer License is a plus. Lean/Six Sigma Green or Black Belt Certification is also desirable.
- Minimum 4-6 years of experience in medical device and/or pharmaceutical manufacturing environment.
- Experience in validations: manufacturing equipment and processes, stability or aging.
- Knowledge of FDA, OSHA, EPA, and GMP's and ISO requirements.
- Strong Project Management skills.
- Ability to lead teams through complex projects with technical leadership.
- Excellent communication skills in English (read, write, and speak). Spanish language proficiency is an asset.
- Able to develop technical documentation such as Change Controls, Validation Plans & Protocols, Technical/investigation reports, SOP, etc.
- Teamwork-oriented and self-starter.
About Labchems Corp.
We are a dynamic organization committed to innovation and excellence in the field of chemical manufacturing. Our team is passionate about delivering high-quality products and services that meet the evolving needs of our customers.
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