Browsing articles in "Job Opportunities"

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

Senior Technical Services Specialist (2 resources) – Puerto Rico, North

Aug 14, 2018   //   by crosado   //   Job Opportunities  //  Comments Off on Senior Technical Services Specialist (2 resources) – Puerto Rico, North

BioPharma Consulting JAD Group is in need of two (2) Senior Technical Services Specialists with experience in Solid Dosage and API Manufacturing Process in the Pharmaceutical Industry for one of our clients in Barceloneta, Puerto Rico.

Position #1: Senior Technical Services Specialists

Requirements: Bachelor degree in Science or Engineering (Preferably Chemical Engineering)

Experience: Must have 5 -10 plus years of experience working on process validation, investigations and CAPA’s, CR for API Manufacturing Process

Position #2: Senior Technical Services Specialists

Requirements: Bachelor degree in Science or Engineering

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

Location: Barceloneta, PR

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

Technical Services – Manufacturing Technology Sterile (Medical Devices), Dallas TX

Jul 17, 2018   //   by crosado   //   Job Opportunities  //  Comments Off on Technical Services – Manufacturing Technology Sterile (Medical Devices), Dallas TX

BioPharma Consulting JAD Group is in need of a resource with experience in Technical Services support in the manufacturing area with solid experience in Sterilization and Autoclave for one of our clients in Dallas TX.

Technical Services – Manufacturing Technology Sterile (Medical Devices)

Education: Bachelor’s degree in science

 Requirements:

  • Minimum 5 years experience
  • Experience working in GMP environment
  • Candidates must have solid knowledge of sterilization and autoclave.
  • Experience with Protocols and Reports Generation, IQ, OQ, PQ, Deviation generation and approval and Investigations

Location: Dallas TX.

Project Duration: 6 month plus

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

Process/Facilities Engineer QC Area – Cambridge, MA

Jan 19, 2018   //   by crosado   //   Job Opportunities  //  Comments Off on Process/Facilities Engineer QC Area – Cambridge, MA

BioPharma Consulting JAD Group is in need of a Process/Facilities Engineer with experience within the Biotech Industry specifically QC area for one of our clients in Cambridge, Massachusetts.

Our client is looking for a Process or Facilities Engineer to support start up and qualification of equipment in QC area. Engineer must be able to work with multiple internal clients to prioritize activities in the area, define requirements and organize activities. The Engineer will be responsible for drafting change controls and working with support groups to perform qualifications. The applicant will be responsible for setting up maintenance schedule and plans for the equipment as well as act as first line of support for the personnel in the area.

Education: Bachelor’s degree in science and 4 years plus of experience in a Biotech cGMP environment, Process, Facilities, QC equipment and facilities.

Requirements:

  • Minimum 4 years’ experience
  • Experience working in GMP environment
  • Experience with project management
  • Understanding of QC lab and activities
  • Experience with large lab equipment (i.e. BSCs, Incubators, Refrigerators)
  • Understanding of lab or GMP construction including power, gas and construction requirements
  • Experience with analytical lab equipment

Location: Cambridge, MA

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

Commissioning, Qualification, and Validation (CQV) – Multiple Positions, Massachusetts

Aug 3, 2017   //   by crosado   //   Job Opportunities  //  Comments Off on Commissioning, Qualification, and Validation (CQV) – Multiple Positions, Massachusetts

BioPharma Consulting JAD Group is in need of multiple contractors and consultants with experience in Commissioning and Qualification within the Biotech Industry for one of our clients in Massachusetts.

Education: At a minimum Bachelors degree in science and 5 years plus of experience in a Biotech cGMP environment.

Candidates must have experience in the following systems/ areas (Commissioning and Qualification):

  • Facilities
  • Equipment (Bioreactors, Media Tanks, Buffer Tanks, Autoclaves, Chromatography Skids and Columns, Parts Washer, etc) 
  • Utilities (Clean Steam, WFI, Deonized Water, compressed air, nitrogen, UV, etc)
  • Process Validation
  • Steam in Place (SIP Sterilization)
  • Clean in Place (CIP)
  • Clean out of Place (COP)

Among other areas and equipment that support Biotechnology Manufacturing.

Candidates must have solid knowledge with Commissioning, Qualification and Validation life cycle documentation (FAT, Commissioning Protocols, Commissioning Reports, IQ, OQ, PQ, Treaceability Matrix, Engineering Runs, etc.)

Positions Available

  • Project Manager
  • Project Lead
  • Validation Engineer
  • Senior Validation Engineer
  • Commissioning and Qualification Engineer
  • Documentation Specialist I & II

Location: Massachusetts

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