Supervisor, Validation

Teva Sicor Pharmaceuticals is a global leader in the manufacture of generic injectable pharmaceuticals. Now a member of TEVA Pharmaceuticals Industries, the world's leading manufacturer and marketer of generic drugs, TEVA Sicor has an excellent opportunity for Supervisor, Validation.

Supervising a staff comprised of 2 to 5 Validation Engineers (Levels I and II) and Technicians to support not only current validation/revalidation programs but also production, Scientific Affairs, and contract manufacturing operations with validated processes/equipment.

Responsibilities:
* Supervise and coordinate activities of 2-5 Validation personnel. Provide technical support and guidance to other validation personnel or project team in protocol/report preparation, execution and data interpretation.
* Reviews validation protocols and uses data analysis skills in assuring accurate interpretation of data.
* Track projects to ensure completion within defined time lines.
* Writing, reviewing, or revising SOPs as related to validation policies or revalidation activities, as needed.
* Independently prepare written validation protocols including designing appropriate test experiments.
* Assists the validation manager in providing technical assistance and handling any questions or concerns from contract customers or agencies in reference to validation activities>
* Follows Teva Safety, Health, and Environmental policies and procedures.
* Other duties, as assigned, or as business needs require.
REQUIREMENTS
Requirements:
* Education Required: Bachelor’s degree in Biological/Life Sciences or Engineering and 4-6 years experience in pharmaceutical manufacturing or related field.
* Experience Required: Minimum of 3 years experience in validation.
* Experience Preferred: Minimum of 4 years experience in validation and at least two years supervisory experience/project management.
* Specialized or Technical Knowledge, Licenses, Certifications needed: In-depth knowledge of validation functions to support manufacturing, cGMPs, CFRs, pharmaceutical equipment and processes required.

Competencies:
Demonstrated proficiency in a minimum of 3 of the following specific areas of validation:
* Terminal sterilization/depyrogenation
* Aseptic processes (filling, compounding)
* Pharmaceutical equipment/systems
* Facilities/utilities
* Computer systems (including PLC)
* Packaging/inspection equipment
* Process validation (fill volume, headspace, etc.)
* Cleaning validation

Technical
* Computer literate and good working knowledge of MS Word, MS Excel, and MS Project, a plus.
* Knowledge of use of instrumentation to conduct validation testing (e.g. Kaye Validator) required.

Planning and Organization
* Results oriented, flexible to adapt to changing priorities, and ability to manage multiple projects required.

Interpersonal
* Ability to interact with all levels of employees from technician level to Senior Management to discuss and resolve validation related issues.
* Frequently interacts with colleagues, team members, supervisors, outside customers, and other teams/departments.

Problem Solving
* Ability to work on problems of increasing complexity where analysis of situation or data requires review of identifiable factors.
* Exercises judgment within defined procedures and policies to determine appropriate action.
* Actively involved to meet schedules or resolve problems.

Communication
* Communicates clearly and effectively, both orally and in writing, project status and results.
* Excellent oral and written communication skills.

As a new member of TEVA Pharmaceutical Industries, Ltd., the world's leading manufacturer and marketer of generic drugs, we regularly seek dedicated and hardworking professionals with the necessary skills for our business.
TEVA Sicor offers a comprehensive benefit package, including major medical, dental, vision, 401(k) and the opportunity to grow with a dynamic company. For immediate consideration, please visit www.tevausa.com. Click Employment Opportunities, then Positions Available and search for Position # 5068. You may also fax your resume to 949-458-8945.