Auftragsdetails

Our client requires a Process Equipment Qualification Validation Consultant for a 6-month, on-site engagement at their Rensselaer, NY facility. Duties and responsibilities include, but are not limited to:

• Qualifying PLC controlled process equipment in a GMP environment.
  • Equipment includes but not limited to, Bioreactors, Chromatography Skids, TFF skids, UF/DF skids, CIP skids.
• Creating qualification protocols (IQ/ OQ/ PQ) and test scripts (alarms, controls, and sequence testing) from engineering design documentation (FDS, SDS, HDS, Alarm List, Interlock List, Valve matrix, etc.).
• Qualifying clean utilities (WFI, Pure Steam, Compressed Air, Nitrogen, etc.)

• Qualified candidates will possess a Bachelor’s degree in related field along with 5 plus years related industry experience.
• Candidates must have excellent verbal communication and technical writing skills.
• Experience in executing protocols including systems such as Process Validation, computer controlled systems validation, utilities, manufacturing equipment such as computer controlled filling systems, formulation systems and basic knowledge of laboratory validation (not required but preferred).
• Familiarity with many aspects of validation is expected.
• Experience with temperature mapping.
• Proficient in Microsoft Word, Excel, Power Point and Project.
• Must be willing to travel regionally and/or nationally throughout the US.

We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.

***ProPharma Group does not accept unsolicited resumes from recruiters/third parties.  Please, no phone calls or emails to anyone regarding this posting.***