Project Validation Spec.

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...

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...

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...

We are seeking a Validation and Sterilization Professional to support our corporate sterilization workstream. As a senior-level professional, you will be responsible for supporting the efficient completion of project-related tasks for the sterilization area.This includes new Ethylene oxide sterilization cycle validation, existing Ethylene oxide sterilization...

Labchems Corp. seeks a highly skilled Validation Specialist to join our team in supporting the EU MDR program. As a key member of our team, you will be responsible for ensuring compliance with EU MDR regulations by conducting thorough gap assessments and developing comprehensive remediation plans. Your expertise in validation activities, project management,...

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...

The role of this position is to provide support to the European Union Medical Device Regulation (EU MDR) program at Labchems Corp. The successful candidate will be responsible for participating in data gathering and compilation of required documentation, conducting gap assessments on manufacturing documentation, and performing remediation tasks.Key...

Labchems Corp. is looking for a Sterilization Process Expert to join our team. As a key member of our sterilization workstream, you will be responsible for ensuring the efficient and timely completion of project-related tasks.Key responsibilities include interpreting microbiological testing data, monitoring and maintaining sterility assurance, and conducting...

We are seeking a highly experienced EU MDR Compliance Specialist to join our team at Labchems Corp. As a critical member of our compliance team, you will be responsible for ensuring that our company remains compliant with EU MDR regulations. Your expertise in validation activities, project management, and technical documentation will be essential in...

Oversees planning, execution, and completion of projects for transferring manufacturing processes, technologies, or products between facilities or locations. Project Planning and Coordination, Stakeholder and Risk Management, Process Optimization, Documentation and Reporting. Coordinates teams across different geographies, ensuring effective communication...

**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,...

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...

Support facilities/construction projects, mainly in Collagen areas. Required to be part of the Core Team of the facilities projects, participate on meetings and review/approve all documentation required such as PCDT, Change Control, EMPQ, equipment qualifications, documents changes, RM changes, calibration/PM documents. Will develop technical documentation:...

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,...

For Quality services in the Facilities area.WHAT MAKES YOU A FIT:  The Technical Part: Bachelor's Degree in Life Sciences, Engineering, or related field and at least three (3) years of previous exposure to Quality Engineering activities within the regulated industry.Bilingual: (Spanish and English) Shift: Administrative & according to business needs ...

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...