Position Title: Validation Engineer II/CSV Engineer
Work Location: Portsmouth, NH 03801
Assignment Duration: 7 Months
Work Arrangement: Hybrid

Position 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.

Background & Context: None specified.

Key Responsibilities:

• 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.

Qualification & Experience:

• Substantial experience in 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.

Working Conditions & Physical Demands (If Applicable): None specified.

Additional Information (If Applicable): None specified.

 
 
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 34.58/hr.