Autoclave Validation Engineer - Oakwood Village, OH (REF7300J)

ProPharma Group is an industry leading, single source provider for regulatory compliance, pharmacovigilance, and medical information services across the full development lifecycle for pharmaceutical, biotechnology, and medical device companies. Operating around the world with offices in Australia, Canada, Germany, Japan, the Netherlands, Sweden, United Kingdom, and the United States, ProPharma Group’s fully integrated service offerings will provide clients with a comprehensive suite of global support services that are required to be competitive in today’s dynamic markets. We build successful long-term relationships with clients by providing leading industry knowledge, experience, and proven processes.

• Validating autoclaves to ISO 13485 requirements.
• Providing 2 autoclaves, 1 liquid load, 4 wrapped goods loads, 30 runs per autoclave.
• Generating some protocol writing.
• Preparing and executing validation documents.
• Project execution for multiple systems validation.
• Understanding the hours budgeted for completion of each task on a specific.
• Individuals must represent the company and division at client sites and interact confidently with clients, contractors, management and peers.
• Develop Installation, Operational and simple Performance qualification documents.

• Qualified candidates will possess a Bachelor’s degree in related field along with 3 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.

All candidates must be legally eligible to work in the United States.

We are an equal opportunity employer. M/F/D/V

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