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Senior Validation Engineer

BCforward Somerset ,NJ
  • Expired: over a month ago. Applications are no longer accepted.
Job Description

Title: Senior Validation Engineer

Estimated Duration: 02 Months Contract  (Possibility for an extension)

Location: Somerset NJ 08873

 

Role Summary/Purpose

Responsible for managing, developing and implementing Equipment and Facility Validation program to ensure compliance with regulatory agency requirements, internal company standards and current industry practices.

 

Specific duties, activities and responsibilities include but are not limited to:

  • Design, develop and lead l::quipment and Facility Validation initiatives.
  • Ensure that the Validation Master Plan remains current.
  • Write, review and execute Equipment and Facility Validation protocols to ensure compliance and adherence to CGMP and Catalent validation standards.
  • Initiate a problem report (change control, CAPA etc) in a TrackWise system.
  • Resolve all non-conformances/deviations and prepare a final summary report for Equipment/Facility Validation protocols.
  • Liaise with manufacturing and laboratory groups in execution of the Validation program.
  • Communicate the Equipm1mt and Facility Validation approaches and requirements during audits.
  • Facilitate a continuous improvement culture within the Manufacturing, Engineering and Quality Control/Assurance environments.
  • Generate and maintain Validation procedures in line with corporate guidelines procedures, CGMP and ISPE standards.
  • Work collaboratively to meet Equipment and Facility Validation deadlines, write reports, give presentations and maintain knowledge and information in area of expertise.
  • Maintain team-working principles within the department and cross-functionally, promoting cooperation and communication.
  • Anticipate and assess/prevent technical problems from impacting product and processes.
  • Achieve results through th,9 development/optimization of people, processes and systems - requirement to harness creativity of multi-disciplined teams.
  • Represent Quality and validation for New Product Development and Release to Manufacturing activities.
  • Manage Validation contractors to complete on-site validation if required.
  • Comply with Health, Safety, and Environmental responsibilities for the position. Other tasks as assigned.

Education: Experience:

  • Degree (Bachelors or Masters) in a technical discipline.
  • Preferred Five (5) to seven (7) years in a CGMP-related industry with at least three (3) to four (4) years of validation industry experience.

 Knowledge/Skills:

  • Code of Federal Regulations and CGMP's relating to the field of validation
  • In depth knowledge of FDA guidelines and ISPE guidelines
  • Demonstrated understanding of process and mechanical engineering
  • Ability to establish clear priorities quickly
  • Ability to work effectively under pressure, handle multiple projects and meet deadlines
  • Strong verbal and written communication skills is a must; ability to interface with all levels of the organization
  • Ability to lead validation project teams
  • Ability to write technical documents
  • PC literate, word processing and spreadsheet software
Company Description
About BCforward
BCforward began as an IT business solutions and staffing firm. Founded in 1998, BCforward has grown with our customers’ needs into a full-service personnel solutions organization. BCforward’s headquarters are in Indianapolis, Indiana and also operates delivery centers in 17 locations in North America as well as Hyderabad, India and Puerto Rico. We are currently the largest consulting firm and largest MBE certified firm headquartered in Indiana. With 14+ years of uninterrupted growth, the addition of two brands (Stafforward and PMforward) and a team of more than 1400 resources our teams deliver services for multiple industries from both public and private sectors. BCforward’s team of dedicated staffing professionals has placed thousands of talented people over the past decade, with retention rates that are consistently higher than the industry average.

www.bcforward.com

BCforward

Why Work Here?

What makes BCforward different is our people and how we do business. We pride ourselves on locating and hiring the best resources in CA.

About BCforward BCforward began as an IT business solutions and staffing firm. Founded in 1998, BCforward has grown with our customers’ needs into a full-service personnel solutions organization. BCforward’s headquarters are in Indianapolis, Indiana and also operates delivery centers in 17 locations in North America as well as Hyderabad, India and Puerto Rico. We are currently the largest consulting firm and largest MBE certified firm headquartered in Indiana. With 14+ years of uninterrupted growth, the addition of two brands (Stafforward and PMforward) and a team of more than 1400 resources our teams deliver services for multiple industries from both public and private sectors. BCforward’s team of dedicated staffing professionals has placed thousands of talented people over the past decade, with retention rates that are consistently higher than the industry average. www.bcforward.com

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Somerset, NJ
08873 USA

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