A Validation Engineer at ProPharma Group will work with our Clients and be responsible for preparing and executing validation documents. Working knowledge of the principles of validation as associated with performance of work for the Pharmaceutical, Biotechnology and/or Medical Device industries. Demonstrate an understanding of GMP. Individuals must represent the company and division at client sites and interact confidently with clients, contractors, management and peers. Protocol development skills will include ability to develop Installation, Operational and simple performance qualification documents. Biologics filling facility; Revamping and Shut down support; Needs General Equipment Validation support for new WIFI system, process piping, Formulation Tank CIP, SIP and Filler cycle development and qualification; needs support with protocol development, execution and summary reports. These are long term (8 months +) projects in the Pacific Northwest and Southern CA
Desired Skills & Experience
- 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 complex systems such as Process Validation, computer controlled systems validation, complex utilities, complex 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. Depth in one or several areas is critical. Possess effective skills for developing, performing, evaluating, and/or troubleshooting PLCs and control systems (including SCADA, Delta V, and BMS systems) is a plus.
- Experience in Process Qualification execution.
- Ability to walk, stand and move about for long periods of time; work with equipment in the field including basic hand tools, lift and manipulate reasonable weights (approximately 35 lbs), ability to sit and type for long periods of time.
- Proficient in Microsoft Word, Excel, Power Point and Project.
- Ability to plan and manage own work.
- Must be willing to travel regionally and/or nationally throughout the US.
All Applicants must be legally eligible to work in the United States.
We are an equal opportunity employer. M/F/D/V