Compliance Team, Inc.

Validation Engineer

US-MO-St. Louis
2 months ago
ID
2017-1159
# of Openings
1
Category
Perm

Overview

Compliance Team, Inc. is assisiting our pharmaceutical partner in St. Louis with their search for a Validation Engineer.  This person will be responsible for the execution of qualification and validation of equipment, utilities, facilities and software programs that are used in the GMP environment. 

Responsibilities

Primary Responsibilities and Essential Functions of the Position:

  1. Develop, Write, Execute Installation Qualifications, Operational Qualifications, Performance Qualifications, and Process Validation Protocols.
  2. Develop and write quality discrepancies and investigations associated with the validation studies.
  3. Work closely with manufacturing, laboratory and QC for sample coordination and to ensure required samples are processed and tested as required during protocol execution.
  4. Work closely with Operations to develop documentation for manufacturing equipment, line set-up and validation requirements.
  5. Ensure validation studies of the manufacturing, quality control facilities, the utilities which serve the facilities
  6. Ensure all manufacturing and testing equipment are completed to the required cGMP standards.
  7. Supervise Production Operators and QC analysts during validation studies as required.
  8. Summarize studies and author validation reports in compliance with the Quality System and cGMP standards.

 

Qualifications

Skills and Abilities Required:

  1. Good working knowledge of cGMP and regulatory standards for validation.
  2. Experience with GAMP Standards.
  3. Strong Technical Writing Skills.
  4. High attention to detail.
  5. Possess excellent computer (MS office: word; excel; access; outlook), writing and editing skills.
  6. Strong sense of urgency on work related matters.
  7. Strong communication skills.
  8. Knowledge in statistics.

 

 

Minimum Education and Experience Required:

  1. Bachelor of Science or Engineering degree
  2. 3 – 5 years experience in performing and leading validation studies within the pharmaceutical industry.

 

 

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