Job Description

Our client has an analytical method developed for a substance that is used in the manufacture of an over the counter, commercial medical device. The client will be manufacturing the product in Maryland and wants to transfer the analytical method. Also, they wanted to validate the analytical method as they will be using the same substance in the manufacture of another commercial product. Lastly, new SOPs are needed for method validation and transfer.

This Contract engagement will last 2-4 weeks.

ProPharma Group is an industry leader providing validation, compliance and technical services to the pharmaceutical, biotechnology, medical device and related industries.  We offer the excitement of a consistently evolving career.  Our team is continually learning and working on new and exciting projects in a variety of regions.  We look for people who excel in their technical area of expertise, believe in our values of Experience, Integrity and Commitment and thrive in the collaborative, rigorous and entrepreneurial spirit of the company culture.

o          Competitive Rates      o          New Experiences        o          Evolving Career

ProPharma Group develops long-term relationships with clients across the country to which we provide a wide array of value-added services that complement and support their core business needs.

• Analytical Method transfer and validation
• 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
• Will work in one or more validation subjects; such as laboratory equipment, facilities utilities, process equipment, packaging equipment, cleaning, computers, HVAC or controls.

Qualifications

• Qualified candidates will possess a Bachelor’s degree in a related field along with a minimum of 7 years of 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.
• 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.

Additional Information

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.