Browsing articles tagged with " Validation"

Senior Process Validation Specialist – Southern California

Sep 5, 2018   //   by crosado   //   Job Opportunities  //  Comments Off on Senior Process Validation Specialist – Southern California

BioPharma Consulting JAD Group is in need of a Senior Process Validation Specialist for one of our clients in Southern California.

Position Summary
The Sr. Validation Specialist serves as the technical subject matter expert for Process Validation within QA and works closely with process development and translational sciences to transfer processes from clinical phases to commercial.  The primary responsibility is to validate processes used and to manufacture GMP clinical and commercial products in compliance with GMP regulations.   This position supports the tech transfer and process qualification efforts at our CMO partners to facilitate transfer to our Thousand Oaks cell therapy facility.

Responsibilities

  • Oversees development of process validation strategies, protocols and other documentation for Cell Therapy products as well as data analysis and compilation of data and results into summary and final reports.
  • Leads process validation related activities for the design, qualification and continued process verification of manufacturing processes, including identification of opportunities for improvement.
  • Reviews/assesses proposed changes to validated processes via CAPA, Change Control and Work Orders to identify requirements necessary to maintain validated status.
  • Works with QA to investigate process issues and perform root cause analysis and implement solutions.
  • Supports Continuous Process Verification (CPV) through strong partnership with Process Science functions.
  • Maintains departmental expertise in process validation and related activities.  As a subject matter expert, represent these activities in discussions and communications with regulatory agencies (e.g., strategizing and preparation of regulatory submissions and in response to agency questions, as well as during facility inspections).
  • Interfaces with other departments (e.g., Engineering, Facilities, Manufacturing, Regulatory Affairs, Quality Control and Quality Assurance) to ensure achievement of objectives relating to process validation and associated activities; including compliance with all applicable standards.

Experience: Must have 5 -10 plus years of experience working on process validation, investigations, CAPA’s, CR, Commissioning and Qualification, Facilities, Utilities for Biotech Process

Location: Thousand Oaks, CA

Project Duration: 6 month plus

For further details or questions, please submit your inquiries and/or your updated resume to: info@bpc-jadgroup.com

Commissioning and Qualification Engineer, Cambridge/Lexington, MA

Jul 17, 2018   //   by crosado   //   Job Opportunities  //  Comments Off on Commissioning and Qualification Engineer, Cambridge/Lexington, MA

BioPharma Consulting JAD Group is in need of a Commissioning and Qualification Engineer with experience with Utilities for one of our clients in Cambridge/Lexington, Massachusetts.

Position: Commissioning and Qualification Engineer – Utilities Systems

Our client is looking for a Commissioning and Qualification (C&Q) Engineer to lead C&Q activities for clean utilities systems in one or two separate facilities in Cambridge, Massachusetts.  Engineer must be able to work with multiple internal clients to prioritize activities in the area, define requirements and organize activities.

Education: Bachelor’s degree in science and 5 years-plus experience with utilities systems in a Biotech cGMP environment.

Requirements:

  • Minimum 5 years’ experience
  • Experience working in GMP environment
  • Experience with clean utilities systems
  • Candidates must have solid knowledge of Commissioning, Qualification and Validation life cycle documentation (FAT, Commissioning Protocols, Commissioning Reports, IQ, OQ, PQ, Traceability Matrix, Engineering Runs, etc.).
  • Experience with C&Q documents development, execution, review and approval.
  • Knowledge of validation paperless software (Kneat) is preferred for this position

Location: Lexington / Cambridge, MA

Project Duration: 6 month plus

For further details or questions, please submit your inquiries and/or your updated resume to: info@bpc-jadgroup.com

Senior Validation Engineer, Cambridge MA

Jul 17, 2018   //   by crosado   //   Job Opportunities  //  Comments Off on Senior Validation Engineer, Cambridge MA

BioPharma Consulting JAD Group is in need of a Senior Validation Engineer with experience within the Biotech Industry for one of our clients in Cambridge, Massachusetts.

Position: Senior Validation Engineer

Our client is looking for a Senior Validation Engineer to support development, review and approval of commissioning, qualification and validation documentation.  Engineer must also be available to participate, as a secondary option, in the execution of C&Q documentation.

Education: Bachelor’s degree in science and 10 years-plus .

 Requirements:

  • Minimum 10 years’ of experience in a Biotech cGMP environment
  • Candidates must have solid knowledge of Commissioning, Qualification and Validation life cycle documentation (FAT, Commissioning Protocols, Commissioning Reports, IQ, OQ, PQ, Traceability Matrix, Engineering Runs, etc.).
  • Experience with C&Q documents development, execution, review and approval.
  • Knowledge of validation paperless software (Kneat) is preferred for this position

Location: Cambridge, MA

Project Duration: 6 month plus

For further details or questions, please submit your inquiries and/or your updated resume to: info@bpc-jadgroup.com