Senior Validation Engineer (1256)

Biotest Pharmaceuticals Corporation

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Location: Boca Raton, FL Posted Date: 4/8/2013 Position Type: Full time Job Code: 282262 Salary: DOE Required Education: Bachelors Degree Areas of Expertise Desired: Engineering

Description

About Biotest

Biotest Pharmaceuticals Corporation researches, develops, and manufactures bio-therapeutic products with a specialization in immunology and liver transplant therapy. Biotest Pharmaceuticals is a leader in the collection of source plasma and is currently involved in the development of plasma protein products in the field of Primary Immune Deficiency (PID) and development of therapies to prevent re-infection of transplanted livers.

Join A Cause - Not Just a Company

Every day, Biotest Pharmaceuticals Corporation employees work tirelessly to help research and manufacture bio therapeutic products related to immunology and hematology. These products have a significant positive impact on the lives of a variety of patients whose immune systems are compromised. When you join BPC, you are joining many hundreds of employees dedicated to saving lives and enhancing the quality of life.

This is our cause!

Job Description   

To provide validation support to Immunotherapy Production, Quality Control, and Plant Engineering. Provide activity update to Department Manager,Validation Services on a regular basis to ensure compliance issues are being met. Interact with FDA investigators regarding validation compliance issues and regulatory requirements. Develop, write and excite equipment, cleaning and utility system validations for product manufacturing and support processes. Review technical and quality system documents such as SOPs, Change Control and Deviation Reports, Batch Production Records, Technical Manuals, and P&Ids, as they relate to validation and regulatory compliance issues. Coordinate validation activities with appropriate departments and contract validation firm employees.

Requirements

Ability to coordinate and complete complex projects; excellent written and oral communication and presentation skills; computer literate in word processing and data entry; extensive experience with Kaye Digistrip and Validator 2000; excellent problem solving skills, detail oriented, and excellent mathematical and advanced statistical analysis skills. Requires extensive reporting such as Validation IQ/OQ/PQs and Validation Final Reports, Project Planning and Annual Evaluation and Operational Assessment Reports of Critical System and Equipment.

Experience Required

Bachelor’s degree in Science or Engineering. Five to seven years validation experience in a cGMP, pharmaceutical/biological manufacturing environment.

Biotest Pharmaceuticals offers an excellent compensation and benefits package including medical/dental/life/AD&D/STD/LTD, matching 401(K), generous paid leave bank, holidays, tuition reimbursement and much more.

Biotest Pharmaceuticals is an Equal Opportunity Employer and Drug-Free Workplace.

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