Senior Validation Engineer

Job Details:-

This is a job posting from company – Bridgetown Consulting Group

Employment TypeFull Time

Work Hours: 8

Salary: $20 To $30/An Hour

Location: Massachusetts, USA

This job is 100% remote.

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Job Title: Senior Validation Engineer

Location: Boston, MA

Duration: Permanent/Fulltime

Job Description:

The Senior Validation Engineer will support a diverse variety of Quality Control and Manufacturing instrumentation, including analytical and microbiological instruments, maintaining the validated state of the instruments from implementation through their full lifecycle. This role will also perform, and lead computer system validation projects related to authoring and executing specifications and validation documentation for automated laboratory systems (e.g., LIMS) per ISPE GAMP 5 guidelines.

Position Responsibilities/Essential Functions:

  • Work with Operations, Quality, Technical groups, and other sites/network groups as required assisting with establishing business and compliance requirements of instrumentation and processes.
  • Responsible to author Qualification packages for a variety of Laboratory Instrumentation and Equipment. Lab equipment may include HPLCs, Chromatographers, Endotoxin Analyzers, etc., and will be subjected to Good Laboratory Practices (GLP) guidelines and principles.
  • Serve as the SME for CSV presentations and maintain knowledge and information in the CSV area of expertise.
  • Skilled in the use of Enterprise systems including, but not limited to site Quality Management Systems (e.g., Veeva Vault, Trackwise), Laboratory Information Management Systems (e.g., LabWare, LabVantage), and Empower and/or Chromatographic applications.
  • Generate validation protocols including Computer System Validation Plan, System Requirement Specification (SRS), Functional Requirement Specification (FRS), Design Specification (Software and Hardware), Commissioning, IQ, OQ, PQ, Summary reports, Requirements Traceability Matrix (RTM).
  • Review and execute Validation protocols to ensure compliance and adherence with corporate guidelines procedures, cGMP and ISPE GAMP guidelines, and FDA regulations.
  • Liaise with manufacturing and laboratory groups in the execution of the Validation deliverables.
  • Facilitate a continuous improvement culture within the Manufacturing, Engineering, and Quality Control/Assurance environments.
  • Work with equipment/system owner(s) to ensure the initiation and implementation of change control activities are per site procedures.
  • Maintain team-working principles within the department and cross-functionally, promoting cooperation and communication working as a strategic partner with all other departments within the company.

Preferred Qualifications:

  • The position requires a BS engineering or science degree with 4+ years of experience or an MS engineering or science degree with 2+ years of experience or equivalent experience working in the pharmaceutical industry (regulated by GMP standards and requirements).
  • Knowledge of Good Laboratory Practices, Analytical Instrumentation Qualifications, Test Method Validation, and Cleaning Validation.
  • Direct experience in the validation of computerized systems in compliance with FDA 21 CFR Part 11 and EU GMP Annex 11 regulations is highly preferred.
  • Lean manufacturing/Six Sigma experience preferred.
  • Familiarity with a variety of concepts, practices, and procedures. Outstanding attention to detail and organizational skills.
  • Knowledge of cGMPs and FDA/industry expectations. Works on projects of moderate to high complexity in compliance with processes and products within facilities, equipment, manufacturing, and support areas.
  • Ability to work multi-functionally.
  • Strong analytical, problem-solving, and conceptual skills.
  • Good verbal and written communication skills.

Thanks & Regards

Nitin

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