Pharmaceutical Validation Specialist – FILLED
The Wellington Group is seeking a top notch Pharmaceutical Validation Specialist to work for a leading research and biotechnology firm. Put your project and facilities validation experence to work…WHILE living in a great mountain community with no traffic and a nice office view!
The proper candidate for this exempt position would be required to set standards, plan, write protocols, execute and author reports for the validation of equipment, processes, facilities and products in the FDA regulated aseptic filling biologic pharmaceutical products area in accordance with cGMPs.
- Develops and implements validation studies on pharmaceutical manufacturing equipment to ensure consistency of data production and concurrence with manufacturer and national standard reference values
- Oversees validation of production processes, performs statistical analysis, develops validation models, and writes process validation protocols and final packages
- Designs and implements systems to assure quality of data processing across multiple study sites.
- Serves as liaison/team member with QA, regulatory affairs, research and development, and manufacturing departments
- Review and develop standard operating procedures in compliance with Good Manufacturing Practice (GMP)
- Performs routine procedures, sample collections, and testing to monitor adherence to environmental, microbiological, or health guidelines
The qualified candidate will have:
- Bachelor’s in science degree (B. S.) from four-year college or university; and two to five years of experience related to validations in a pharmaceutical or biotech environment and/or training; or equivalent combination of education and experience.
- Aseptic manufacturing knowledge is a plus, clean room is ideal
- Hands on with aseptic filling equipment and facilities, autoclaves, lab test equipment, HVAC and WFI systems is preferred
- Self-driven and accountable, will be required to jump in, diagnose the issue and solve the problem
- Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry
- Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations
- Knowledge of United States Pharmacopeia/National Formulary analytic methods; Knowledge of statistical process control (SPC) and design of experiment (DOE) is desired but not required
Industry: Biologics, Pharmaceuticals, Validation
Permanent position with an employee centered company offering great benefits, salary, bonus and relocation assistance.
Don’t wait, apply with The Wellington Group today!
(all information will be held in the strictest of confidence)