Validation Process Engineer

Job Description
Basic Function and Responsibility:
Responsible for performing and leading Technical Service and Validation studies at G&W laboratories

Work Performed:

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, Water Systems Validation, Equipment Qualifications, Packaging Validation and other projects as necessary.

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

Prepares protocols, collects data, analyzes data and prepares final reports

Prepares, maintains and evaluates Cleaning Validation Matrix

Revises and improves the master batch record, Official Forms and Standard Operating Procedures

Prepares Change Controls and performs tasks associated with the CCR

Performs thorough document reviews and has an attention to detail

Researches Process history per APR system and recommends process improvement projects.

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

Aids in investigation writing and customer complaint investigations.

Creates Batching and cleaning recipes for the Becomix and Unimix.

Other tasks as assigned by Technical Services management.


Aspects of Performance:

Maintains confidentiality

Possesses sound analytical problem-solving and documentation skills

Demonstrates ability to prioritize conflicting demands

Must be able to bend repeatedly and lift up to 50 lbs

Executes assigned tasks within established schedules

Writes and speaks clearly and concisely

Develops and maintains expertise through continuing professional education and training

Complies with Company policies, procedures, rules and regulations

Attention to detail

Strong communication skills

Understanding of Manufacturing processes

Must be fluent in Microsoft Word, Excel, Access, Project and Powerpoint



Education:

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

Experience

0-5 years of pharmaceutical experience

Company

G & W Labs

Job Code

State or Province

New Jersey

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