Production Process Specialist

hace 1 día


Añasco, Puerto Rico Labchems Corp. A tiempo completo

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.



  • Añasco, Puerto Rico Flexible & Integrated Technical Services, Llc A tiempo completo

    **Company Overview**Flexible & Integrated Technical Services, LLC is a full-service provider of engineering, construction, maintenance, utilities, and specialized technical services. Our company is committed to providing exceptional quality talent to clients in the Pharmaceutical, Medical Device, and Manufacturing industries.**Job Requirements**We are...


  • Añasco, Puerto Rico Flexible & Integrated Technical Services, Llc A tiempo completo

    **About Us**Flexible & Integrated Technical Services, LLC is a unique service provider that integrates engineering, construction, maintenance, utilities, and specialized technical services across the island and in the US. We pride ourselves on treating our resources like family while delivering top-notch quality talent to clients in the Pharmaceutical,...

  • Process Engineer

    hace 3 semanas


    Añasco, Puerto Rico Flexible & Integrated Technical Services, Llc A tiempo completo

    For Validation services in the Facilities area.WHAT MAKES YOU A FIT:  The Technical Part: Bachelor's degree in Engineering and a minimum of five (5) years of exposure in Validation activities within the Pharmaceutical or Medical Device Industry.Excellent verbal/written communication skills (English and Spanish)  Shift: Administrative & according to...


  • Añasco, Puerto Rico Labchems Corp. A tiempo completo

    Support the European Union Medical Device Regulation (EU MDR) program with the following activities: Data Gathering–Participate in the discovery and compilation of required documentation to be evaluated. Gap Assessments–Assess of all manufacturing documentation such as product device master record (drawings, specifications, bill of materials, production...


  • Añasco, Puerto Rico Kelly Science, Engineering, Technology & Telecom A tiempo completo

    The position is to support the implementation of labeling / artwork changes on Duragen product family for CE and non-CE marked SKUs. The incumbent will be supporting the following activities to ensure conformance with global labeling SOP for Duragen products manufactured at Integra Añasco.• Data Gathering – Participate in the discovery and compilation...


  • Añasco, Puerto Rico Labchems Corp. A tiempo completo

    **Job Summary:**Labchems Corp. seeks a highly skilled Quality Assurance Specialist to support our facilities and construction projects in Collagen areas.The ideal candidate will be part of the Core Team, participating in meetings and reviewing/approving all documentation required for project success.This role involves developing technical documentation,...


  • Añasco, Puerto Rico Labchems Corp. A tiempo completo

    The position is to support the European Union Medical Device Regulation (EU MDR) program. The incumbent will be supporting the following activities: -- Data Gathering-Participate in the discovery and compilation of required documentation to be evaluated. -- Gap Assessments-Assess of all manufacturing documentation such as product device master record...


  • Añasco, Puerto Rico Labchems Corp. A tiempo completo

    At Labchems Corp., we are seeking a Senior Validation Specialist to support the efficient completion of project-related tasks for the sterilization area. This includes new Ethylene oxide sterilization cycle validation, existing Ethylene oxide sterilization cycle re-validation, and sterilization cycle improvements.The ideal candidate will have advanced...


  • Añasco, Puerto Rico Kelly Science, Engineering, Technology & Telecom A tiempo completo

    Job Overview: Kelly Science, Engineering, Technology & Telecom is seeking a highly skilled Senior Quality Assurance Specialist to join our team. This role will be allocated to work with facilities and construction projects in Collagen Manufacturing areas.Main Responsibilities: The successful candidate will participate in meetings, review and approve...


  • Añasco, Puerto Rico Flexible & Integrated Technical Services, Llc A tiempo completo

    **Job Summary**We are seeking a highly skilled Quality Control Engineer - Medical Devices to join our team! As a key member of our Quality Engineering team, you will be responsible for investigating manufacturing product quality and compliance issues, analyzing results, making recommendations, and developing reports. You will also optimize manufacturing...


  • Añasco, Puerto Rico Labchems Corp. A tiempo completo

    Job Overview">At Labchems Corp., we are seeking a highly skilled Quality Assurance Specialist to support our facilities and construction projects. As a key member of the Core Team, you will participate in meetings and review/approve all documentation required for facility projects. Your primary responsibilities include developing technical documentation,...


  • Añasco, Puerto Rico Flexible & Integrated Technical Services, Llc A tiempo completo

    We are a Service Provider company different from the rest. Flexible & Integrated Technical Services, Llc prides ourselves in how we treat the most important piece of our company's puzzle: you**Job Summary:**This role will be responsible for ensuring timely and thorough execution of Computer System Validation protocols, meeting FDA requirements. You will...


  • Añasco, Puerto Rico Labchems Corp. A tiempo completo

    Company OverviewLabchems Corp. is a leading manufacturer of high-quality laboratory chemicals and equipment. Our commitment to innovation and customer satisfaction has earned us a reputation as a trusted partner in the scientific community.Job DescriptionWe are seeking a highly skilled EU MDR Compliance Specialist III to join our team. The successful...


  • Añasco, Puerto Rico Flexible & Integrated Technical Services, Llc A tiempo completo

    About Our CompanyFITS is a unique service provider company that integrates Engineering, Construction, Maintenance, Utilities, and Specialized Technical services across the Island and in the US. We value our resources' well-being and provide top-notch quality talent to our Pharmaceutical, Medical Device, and Manufacturing industry clients.Job OpportunityWe...

  • Engineer - Quality

    hace 5 días


    Añasco, Puerto Rico Flexible & Integrated Technical Services, Llc A tiempo completo

    For Quality Engineering services in the Manufacturing area.  WHAT MAKES YOU A FIT:  The Technical Part: Bachelor's degree in Sciences or Engineering and previous exposure in Quality Engineering activities within the Medical Devices or Pharmaceutical industry.Excellent computer skills Bilingual: Spanish and English (verbal/ written) Shift: Administrative...

  • Manufacturing Engineer

    hace 4 semanas


    Añasco, Puerto Rico Eqval A tiempo completo

    EQVAL Consulting Group, Inc.  is a company that provides services to the manufacturing industry ( Medical Devices, Pharmaceuticals, Biotechnologies, others ).We work with an extraordinary group of professionals ( employees and contractors ) to accomplish the requirements established by our customers, in order to perform and provide a highly effective...

  • Quality System Specialist

    hace 4 semanas


    Añasco, Puerto Rico Flexible & Integrated Technical Services, Llc A tiempo completo

    For Quality services in the Manufacturing area.WHAT MAKES YOU A FIT:  The Technical Part: Bachelor's Degree in Science or Engineering and at least two (2) years of previous exposure to Quality Systems activities within the regulated industry.Bilingual: (Spanish and English) Shift: Administrative & according to business needs  Experience in: Computer...

  • Csv Specialist

    hace 2 semanas


    Añasco, Puerto Rico Flexible & Integrated Technical Services, Llc A tiempo completo

    For Computer System Validation and Software services in the Manufacturing area.WHAT MAKES YOU A FIT:  The Technical Part: Bachelor's Degree in Life Sciences or Engineering and previous exposure in Computer System Validation activities within the regulated industry.Bilingual, Spanish, and English.Shift: Administrative & according to business needs ...