Sr Validation Engineer

JOB DESCRIPTION

Job Title: Senior Validation Engineer

Reports To: Sr. Director, Technical & Validation Services

Responsibilities:

Manage, establish, and execute programs covering all phases of validation for all products, processes, equipment, computer, and cleaning.

Typical Duties:

1. Manage, coordinate, and prioritize the Validation Program for process, equipment, computer, and cleaning protocols for: formulation, labeling, filling, packaging for all products, and all support systems.
2. Assure compliance with GMP's and all Regulations/ policies and procedures.
3. Collect, collate, and analyze validation data and prepare final validation reports for approval by management.
4. Write validation protocols for cleaning, process, equipment, and computer validations.
5. Review and approve validation protocols and reports.
6. Support all audit activities pertaining to Validation.
7. Provide technical assistance to personnel when needed for drafting validation protocols, implementations as well as writing reports.

Job Specifications:

• Engineering or Technical Degree, with Science major.
• Experience in a pharmaceutical environment with one-two years in enforcement compliance.
• Working knowledge of GMP's, statistics and Validation/Qualification of equipment, cleaning, computer, and processes.

The support and promotion of the MGP Compliance Program (MGP Standards of Ethics & Conduct) is an essential element of the performance standards and will be used in the overall performance ratings.