Sr. Validation Specialist

Location : Raleigh, NC

Salary : $110-$115 / k

DIRECT HIRE

SUMMARY OF POSITION :

Authors, executes, and summarizes validation protocols. Coordinates and manages validation project execution for equipment, critical utility, and computer related systems. Ensures protocols, records, and procedures are in compliance with current Good Manufacturing Practices (cGMP) and approved SOPs. Support investigations for critical equipment, processes, and utilities.

ESSENTIAL FUNCTIONS :

Coordinate and execute validation studies, writing protocols, documenting results, and, generate final reports, and summaries of work for release of equipment tested.

Develops and revises new or existing procedures to insure compliance to cGMP, GLP, and FDA regulations.

Conducts special projects as directed by management.

Provides technical advice on new equipment and modification to existing equipment to ensure validation / qualification status is maintained in a state of control.

Provides technical assistance and training for personnel.

Recommends changes in policies and procedures, to management, to enhance the company's ability to conform to and maintain compliance with site, corporate and regulatory standards.

Notifies and recommends to management course of action when critical instruments, systems or processes are found to be out of specifications.

MINIMUM REQUIREMENTS

BS Degree in engineering / life sciences or equivalent validation experience.

2-6 years of validation experience in a pharmaceutical environment.

Working knowledge of cGMP, GLP, and FDA regulations. Knowledge of typical pharmaceutical equipment.

Ability to read, analyze, and interpret Validation protocols, SOPs, technical procedures, or governmental regulations.

Ability to write protocols, reports, business correspondences and procedures. All communication must be in English, using good grammar and appropriate vocabulary.

Ability to comprehend and apply principles of calculus, modern algebra, and advanced statistical theory.

Ability to define problems, collect data, establish facts, and draw valid conclusions from these observations.

Computer Skills : Ability to utilize MS Office (Word, Excel, Powerpoint, Access), Databases, Must have a working knowledge of the fundamentals of steam sterilization, cleaning validation, and equipment qualification.

Skills / Competencies

Candidate should possess experience in laboratory systems, particularly those with computer controlled functions, and cleaning and sterilization process validation.

Self-motivated, energetic, enthusiastic, and team oriented.

Requires the ability to apply analytical and scientific principles for solving problems and for properly designing validation test cases.

Must have a demonstrated comprehension of high level mathematics (i.e., calculus and / or statistics), and technical writing.

Candidate must have excellent computer software usage skills including, but not limited to MS Word, MS Excel, and MS Access.

Must have excellent knowledge of mechanical equipment engineering and software functional testing

Candidate must possess personal drive and the ability to schedule work assignments so that they are concluded in a timely, complete, and error-free manner with the highest level of accountability

Effective communication with both team members and other plant support groups.

All qualified applicants will receive consideration for employment without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, medical condition, genetic information, pregnancy, or military or veteran status. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the California Fair Chance Act, City of Los Angeles' Fair Chance Initiative for Hiring Ordinance, and Los Angeles County Fair Chance Ordinance. For unincorporated Los Angeles county , to the extent our customers require a background check for certain positions, the Company faces a significant risk to its business operations and business reputation unless a review of criminal history is conducted for those specific job positions.