Responsible for performing and leading Technical Service and Validation studies at G&W laboratories.

Responsible for all aspects of validation activities, including writing protocols and reports, complying with Good Manufacturing Practices (CGMP), Standard Operating Procedures (SOP) and Food and Drug Administration (FDA) requirements.

Projects include: Alternate API/Excipient qualification, scale up/down, Submission batches, Technical Transfers, Process Improvement projects, Process Validation, Cleaning Validation, and other projects as necessary.

Takes a leadership role on TS projects. Coordinates activities within and across departments. Coordinates project meetings as needed and prepares meeting minutes.

Prepares, maintains and evaluates Cleaning Validation Matrix. Experience in calculating Maximum Allowable Carryover (MAC) residue limits for Active Ingredients and Detergents. Develops Cleaning SOPs and cleaning recipes (CIP) for processing and packaging equipment.

Revises and creates the master batch record. Creates batching recipes for automated processing systems.

Prepares Change Controls and performs tasks associated with the Change Control.

Recommends process improvement projects.

Aids Manufacturing and Packaging in troubleshooting, problem solving and product impact analysis.

Strong communication skills.

Understanding of Semi-Solid Manufacturing processes.

Must be fluent in Microsoft Word, Excel, Visio and Project.

B.S. in Physical Science (Engineering, Chemistry, Pharmacy, etc.)

1-5 years of pharmaceutical experience.

Process Validation experience is required.

Cleaning Validation experience is required.

Semi-solid experience is a plus.