Lead/Sr Computer System Validation Engineer

Job Title : Lead/Sr Computer System Validation Engineer

Location: Muskegon, MI (Onsite)

Role Responsibilities:

• The CSV Lead manages quality control checks on engineering project work.
• The CSV Lead will have 10 plus years of experience of automation systems computer systems validation in a GMP environment.
• The CSV Lead will be responsible to assist Client in designing the validation strategy for the overall project and to coordinate production of the required CSV protocols.
• The CSV Lead will provide leadership to the CSV team members in reviewing CSV protocols for the various streams and ensuring that they are executed in accordance with Client policy and the relevant Project Plan.
• The CSV Lead will liaise closely with Client Quality to ensure that customer quality expectations are met with respect to CSV and provide guidance to the Client.
• Systems including DeltaV, Historian, MES, ABB as well as other DCS and OT systems.

Requirements:

• The Validation Lead responsibilities include:
• Project master validation planning
• Setting of project CSV guidelines
• Setting of GDP, cGMP & GAMP project guidelines
• Quality review of project documentation
• Quality review of testing documentation
• Review of validation documentation
• Attendance at testing stages
• Attend and participate in daily client site meetings
• Familiarity with relevant pharmaceutical / Life Sciences industry standards.
• Familiarity with validation of DeltaV, MES, Historian, ABB and other OT systems.
• Typically 11+ years relevant pharmaceutical / Life Sciences industry experience