Validation Specialist I
76 New York Ave, USMA0118 Framingham, MA
Assist site Validation personnel through the generation and execution of select requalification and other qualification protocols as required (typically using existing protocol and report templates). Duties will also include supporting overall maintenance of the Validation program (e.g. validation records management, scheduling execution activities with system owners).
- General knowledge of cGMP manufacturing and cGMP requirements.
- Ability to review and perform basic statistical analysis on collected data (e.g. average, standard deviation).
- Well-developed communication skills, both verbal and written.
- Experience with data acquisition systems (e.g. Kaye)
- Experience in cGMP manufacturing.
- BSc/BEng plus previous experience in CQV field or equivalent combination of education and experience.
- Experience in pharmaceutical/biopharmaceutical industry or related industry/cGMP environment.
Preferred areas of experience:
CIP/SIP, component prep equipment (e.g. autoclave).
Kaztronix is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, sex, age, religion, disability, veteran status or any other consideration made unlawful by federal, state or local laws.In addition, all human resource actions in such areas as compensation, employee benefits, transfers, layoffs, training and development are to be administered objectively, without regard to race, color, religion, age, sex, national origin, disability, veteran status or any other consideration made unlawful by federal, state or local laws.