In this job, you will be expected to lead and/or assist with the planning, engineering studies, data evaluation, protocol writing, execution and report writing for our pharmaceutical facility and equipment validation program. This position is hands-on at every phase of the process. You will work with senior QA personnel on these activities, but you must be self-motivated and a self-starter. You must have enough validation experience to accomplish these activities with a modest amount of direction and oversight. You must have a good working knowledge of validation methodology and be able to modify or develop methods as needed. You must be able to write protocols that are clear, complete and detailed and that will conform to our company’s format. You will work with operators and analysts in manufacturing, facilities and quality control to accomplish the design and execution of validations, including the collection of samples and the testing of samples.
- Has direct experience in planning and performing equipment, lab ware and facility cleaning validation OR Several years of industry experience within pharmaceutical Manufacturing or Quality Control and a desire to move into Quality Assurance and Validation
- Interest in Equipment and data analysis
- Has working knowledge of US and European GMP regulations.
- Must be self-sufficient and also be able to work within a team.
- Must be able to perform basic laboratory techniques such as preparing dilutions.
- Can independently evaluate situations, draw conclusions, and propose solutions.
- Has strong work ethic, detail oriented, and sense of responsibility.
- Must read and write English proficiently.
- Must be able to communicate clearly and professionally both in writing and verbally.
- Must be able to use Excel proficiently and Word adequately.
- Ideal if you have direct experience in planning and performing equipment and facility validation in a pharma environment
- Ideal if you have experience with GE/Kaye validators, dataloggers, and cleaning validation
- Regular duties will require some physical effort such as stretching, crouching, and lifting, working around large process equipment, and working in laboratories, fume hoods and BSCs. Access to production and testing areas requires specific gowning requirements.
- Bachelors or Associates Degree/Certificate in Biotechnology-Biomanufacturing with 2 plus years’ experience in validation within a GMP pharma manufacturing environment.