Validation Engineer

Validation Engineer Tri-Pac, Inc.  a contract development and manufacturing company (CDMO) specializing in liquid and aerosol filling for personal care and pharmaceutical marketers, is seeking for a  Validation Engineer.

Job Description :

• The Validation Engineer will demonstrate his / her knowledge of biologics manufacturing processes, including fermentation, purification, and bulk filling processes and work independently in a matrix team environment, influencing team decisions, and exercising sound judgement in determining compliant and robust validation approaches.  He / she will have the ability to multi-task with a demonstrated track record in meeting deliverable timelines and must demonstrate the ability to think critically and analytically with acumen for troubleshooting and problem solving and is a strong team player aligned with company corporate values.  Will have good interpersonal, verbal, and written communication skills and has the ability to function effectively and independently in a fast-paced and dynamic environment.  He / she is self-motivated and willing to tackle assignments and development opportunities outside of job scope as needed.  Has the ability to interpret engineering and facility drawings such as facility layouts, blueprints, material / process flow diagrams, and equipment P&IDs.  Is an expert with Microsoft Word / PowerPoint and Intermediate Microsoft Excel skills and understands basic statistics, acceptance sampling, and is familiar with statistics software.  Demonstrates hands on experience with facility / equipment / utility qualification, cleaning validation, process validation, and sterilization validation experience (steam sterilization and dry heat depyrogenation) in GMP environment and with CIP / SIP cycle development.

Responsibilities :

Education and / or Experience :

Expertise in the following areas is must :

Tri-Pac, Inc. is an Equal Employment Opportunity / Affirmative Action Employer To Staffing & Recruitment Agencies :