Auftragsdetails

Our client requires a Cleaning Validation / Autoclave Sterilization Support Consultant for a 3-6 month, on-site engagement at their Rensselaer, NY facility. This position will support cleaning validation activities and autoclave qualifications. The resource will support one of two areas: support for a new fill-line, and the fill/finish area.

• New Fill line area support of the following activities:
  • Rinse/swab sampling support of bioreactors, chromatography skids
  • Support autoclave load configuration development
  • Review and complete validation summary reports (approximately 100 in backlog) and deviations
  • Using a paper based system, may transition to Valgenesis in the future
  • Experience with Steam-in-Place (SIP) systems and Kaye or E-Labs a plus
• Fill/Finish area support of the following activities:
  • Cleaning validation support of fill/finish equipment including development of cleaning cycles i.e., parts washers, lyophilizers, etc.
  • Support media fills on filling lines
  • Cleaning/sterilization validation of isolator VHP units
  • Perform root causes analysis' related to investigations as needed
  • Review and complete validation summary reports

• 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.***