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Validation Engineer (Pharma)

HonorVet Technologies Kalamazoo ,MI
  • Expired: over a month ago. Applications are no longer accepted.
Job Description

 

Validation Engineer PROCESS ENGINEER --- URGENT Need!!

Kalamazoo - MI

6 months contract

• Bachelor’s Degree: Engineering degree preferably mechanical or chemical (with 2-3 yrs experience)
• Manufacturing experience mandatory (highly prefer Pharma Manufacturing)
• Strong Technical Writing skills
• Prior pharmaceutical experience and knowledge of FDA’s Good Manufacturing Practices (GMPs) are strongly desired
• Lean/Six Sigma experience also desired

PROCESS ENGINEER --- URGENT Need!!

*QAR/CAPA/GCR/Epif/VT/Production Support*

Area Overview
The Sterile Preparation (aka Sterile Prep or Prep) supports the injectable manufacturing and filling process at the Kalamazoo site. Sterile Prep cleans, assembles and sterilizes parts and components used in the aseptic filling process. The area also has responsibility for preparation (clean/sterilize/siliconize) of stoppers used to seal product vials.
Role Description
The process engineer will support the Sterile Prep operation providing technical assistance in investigating process deviations, identifying and implementing corrective and preventive actions, and writing deviation reports summarizing the investigation.

The role will also provide technical support to production as required to troubleshoot equipment problems and identify equipment and process improvements.

Equipment utilized in Sterile Prep includes automated parts washers, dry heat ovens, autoclaves, vaporized hydrogen peroxide chambers, and automated stopper processors.
The role will interact routinely with other process engineers, production supervisors and operators, Quality, Cleaning Validation, Maintenance, and Environmental Health and Safety. The process engineer will be expected to spend time in the production area which will require special gowning and PPE.
The work is primarily on 1st shift Monday through Friday, but may require some interaction with 2nd and 3rd shifts.


Requirements
• Engineering degree preferably mechanical or chemical.
• Knowledge and experience with Microsoft applications (Word and Excel)
• Strong technical writing skills
• Good communication and teamwork skills
• Prior pharmaceutical experience and knowledge of FDA’s Good Manufacturing Practices (GMPs) are strongly desired
• Lean/Six Sigma experience also desired

POSITION NOTES:
- position will consist of supporting the floor, conducting investigations of incidents/deviations that occur; working with production operations/supervisors to review these & how to resolve; reviewing SOP's, writing reports, etc.
- will also involve equipment + general process issues with troubleshooting
- duration: at least through the end of the year - potential to extend beyond that based on work volume/business needs

SKILLS NOTES:
- Bachelors Degree with at least 2-3 yrs experience
- mandatory Manufacturing Exp
- highly prefer Pharma Manufacturing exp!!
- Technical writing skills very important + mandatory

 

 

Company Description
HonorVet Technologies is a technology-driven company that provides the reach of a large staffing organization with the feel of a specialized, boutique provider. Our purpose is to lower the underemployment in the Veteran community by providing them with best-fit opportunities in civilian workplaces. We are disrupting Talent Acquisition with advanced recruitment solutions, a unique combination of Predictive Analysis, Artificial Intelligence, Processes, and Methodologies to support the company’s “High Touch” Expertise. HonorVet Technologies deliver ideal recruitment solutions to our clients with suitable skillsets (preferably veterans, along with non-veterans, for the hard-to-fill positions).

HonorVet Technologies

HonorVet Technologies is a technology-driven company that provides the reach of a large staffing organization with the feel of a specialized, boutique provider. Our purpose is to lower the underemployment in the Veteran community by providing them with best-fit opportunities in civilian workplaces. We are disrupting Talent Acquisition with advanced recruitment solutions, a unique combination of Predictive Analysis, Artificial Intelligence, Processes, and Methodologies to support the company’s “High Touch” Expertise. HonorVet Technologies deliver ideal recruitment solutions to our clients with suitable skillsets (preferably veterans, along with non-veterans, for the hard-to-fill positions).

Address

Kalamazoo, MI
USA

Website