We are looking for a Sr Computer Systems Validation with some DeltaV experience.
Location- North of Boston
6-12 months Contract
Phone interview followed by in person /Skype Interview.
Please forward your resume in MS Word format ASAP if you are interested OR refer anybody you know.
Turnkey team that will be responsible for the validation of a new DeltaV implementation.
Team will need to adhere to the client's SOPs, templates, and process for Validation.
Working with the Engineering team, the Validation team will modify requirements and configuration documentation to develop test scripts.
Not sure if we need to develop Validation Master Plan (VMP) as this may be done, regardless the team will be responsible to develop the scripts, dry run, execute and document.
Anticipate a Lead and possibly 6- 9 members.
The Lead MUST BE HANDS ON, only 20% of their time will be in PM role rest will be in execution / doer role.
Certainly the lead is more senior and has managed a team
Validation of Process Control Software (3+ years)
DeltaV version 13 or higher a + (a plus)
Life Sciences industry knowledge (pharma, biologics, med device acceptable) - this is a must GMP knowledge with a detail understanding of CSV (Part 11 must be seen in their resume)
Willing to work onsite (MA location) - we may change this
Work well within a team
We have divide Script Development from Execution (what we mean is more senior members may do the script development and collaborate with the engineers) while the junior members will conduct dry runs, work to revise / clarify the scripts as necessary, and execute.
Best guess right now is knowledge of the V model for validation would be appropriate (will help weed out junior vs. senior).