Associate Validation Specialist Scientific Protein Laboratories

PRIMARY OBJECTIVE OF POSITION:
With support from senior validation personnel, prepares and executes validation protocols for cGMP processes, and production and laboratory equipment in compliance with Q7. Writes final reports for executed validation protocols.
DUTIES AND RESPONSIBILITIES:
1. Reviews equipment manuals/technical literature in support of writing and executing protocols. Reviews engineering and maintenance drawings and documents. Works closely with all other SPL departments.
2. Writes installation/operation/performance qualification protocols for new and existing production and laboratory equipment with support from the senior validation personnel.
3. Reviews process and product documentation and prepares the appropriate process, software, and cleaning validations.
4. Executes the prescribed tests/challenges contained in the installation/operation/performance qualification, process validation, software validation, and cleaning validation.
5. Writes interim and final reports as necessary at the conclusion (or appropriate intermediate step) of a validation or revalidation study with support from the senior validation personnel. Collects and organizes all relevant and required documents into the validation binders.
6. Prepares and distributes validation status reports and change control status reports on a scheduled basis.
7. Provides technical assistance to all other departments regarding validation issues.
8 Writes, revises and follows department and company SOPs.
9. Other duties as assigned.
JOB STANDARDS
A. Education: Minimum of a Bachelors degree in Chemistry, or other related scientific discipline is required. Degree requirements may be substituted by year-for-year work experience in a directly related position. Knowledge of Validation techniques and theories is desired.
B. Experience: Minimum of one (1) year of previous Validation experience in a pharmaceutical and/or Bio-Tech. environment is required.

C. Standards: Must have excellent written and oral communication skills as well as excellent interpersonal skills. Must have a good understanding of cGMPs and related documentation requirements. Familiar with ICH Quality Guidance Documents preferred. Demonstrated proficiency in math, reading, computers, typing and writing skills as well as attention to detail. Must be able to organize and schedule time effectively. Must be able to perform with little direct supervision. Good attendance is required. PC literacy is required.
D. Work Environment: Work area is typical of an office environment. Some production execution testing of the processes may require dust masks, respirators, protective clothing/equipment to handle a variety of chemicals and raw animal tissue. Overtime or second shift work may be required.
E. Physical Standards: Job requires standing, sitting, walking, bending, twisting, squatting and reaching. Frequent lifting of 1 20 lbs. And occasional lifting of 21 75 lbs.

Location:	P.O. Box 158 Waunakee, WI 00000 United States