ATL03-052225 CQV Engineer/Specialist�Utilities or Automation/CSV (MA)
ATL03-052225 CQV Engineer/Specialist�Utilities or Automation/CSV (MA)
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Salary Not Disclosed
1 Vacancy
Job Description
Validation & Engineering Group Inc. (V&EG) is a leading services supplier providing solutions for the Pharmaceutical Biotechnology Chemical Food and Medical Devices industries in the areas of Laboratory Compliance Computer Engineering Project Management Validation and other technical services.
We are currently seeking a CQV Engineer with experience in either clean utility systems or automation/CSV to support commissioning and qualification activities for a major GMP manufacturing project. This role requires availability to work in production packaging and construction areas following site safety quality and gowning requirements.
Location: Norwood MA
Responsibilities:
Prepare and execute commissioning and qualification (C&Q) protocols related to clean utilities and/or GMP automation systems.
Systems may include:
Utilities: Clean Steam distribution WFI storage and distribution compressed air systems (compressors dryers dry receivers) process air distribution and secondary lift stations.
Automation/CSV: Level 4 SCADA orchestration layer continuous monitoring systems (CMS) process control systems (PCS) data historian systems (DHS) and related PLC-based platforms.
Participate in FAT SAT Start-up IOV IOQ and PQ activities as applicable to assigned systems.
Support discrepancy resolution and ensure traceability to applicable URS and design documentation.
Interface with Quality Engineering and Digital teams to ensure testing and documentation meet current site procedures and regulatory requirements.
Qualifications:
Bachelors degree in engineering life sciences or a related field.
Minimum 5 years of CQV experience in either clean utility systems or automation/CSV systems for GMP manufacturing.
Familiarity with GAMP5 21 CFR Part 11 Annex 11 and data integrity principles.
Strong documentation and protocol execution skills.
Ability to work independently in dynamic construction and operational environments.
Must be able to follow gowning safety and GMP procedures in classified and active areas.
Required Experience:
Unclear Seniority
Employment Type
Full Time
