6190 CSV Engineer

Hybrid

Job Summary:
The CSV Engineer will, as an individual contributor, identify and implement industry best practices through an extensive industry network and detailed knowledge of applicable regulations.
During the scoping portion of these improvement projects the person in this role will work with other experienced members of the CSV team to identify roadblocks and additional efficiencies.
Additional day to day tasks will include risk assessing systems, reviewing change requests and test scripts, drafting protocols and initiating and reviewing GMP documentation revisions.
Execute all responsibilities as the CSV owner for significant site and process improvement projects, to ensure compliance to appropriate regulatory requirements and industry standards while maximizing efficiency.
Perform all aspects of QMS process’ – Change Control (particularly associated with DCS ( DeltaV) and MES ( Syncade) systems, Deviations, CAPAs. Perform other duties as assigned.

Key requirements include:
Substantial experience in equipment and/or computer validations. Must have Working experience with Controls Automation, Process Control Systems, Distributed Systems, Manufacturing Execution Systems (MES) required, DeltaV preferred.
Prior experience leading projects in a Biotech/Pharma or biologics industry.
Strong attention to detail and ability to work independently and meet deadlines successfully.

The hiring range for this position is $47.00-$57.00 per hour. The base pay actually offered will take into account internal equity, and may also vary depending on candidate’s geographic region, job-related knowledge, skills, and experience amongst other factors.

Harvest Technical Services is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, Sexual orientation, national origin, genetics, pregnancy, disability, age, veteran status, or any other federal, state, or local protected class.