Validation Principal Engineer - Cook Pharmica
Cook Medical - Bloomington, IN

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Cook Pharmica is a biopharmaceutical contract development and manufacturing organization (CDMO) with process development, clinical and commercial bulk drug substance manufacturing, formulation development, clinical and commercial parenteral drug product manufacturing, including liquid and lyophilized vials, prefilled syringes and secondary packaging, and an array of support services all at a single facility in Bloomington, IN. Founded in 2004, Cook Pharmica is a division of Cook Medical, the world's largest privately held medical manufacturing company.

Primary Function

To participate in validation projects relating to biopharmaceutical and pharmaceutical manufacturing equipment, critical computer systems, manufacturing processes and laboratory documentation.

Essential Job Functions/Duties
• Coordinate multiple projects and work of others

• Document activities via protocols and summary report templates; establish new templates and policies as needed.

• Review facility changes and provide input on re-validation activities

• Assess risks involved in processing steps and related to equipment

• Develop and/or review validation requirements and design deliverables

• Partner with contract validation teams to support and monitor efforts

• Monitor facility validation strategies and ensure polices are followed

• Conduct validation studies in accordance with batch records/protocols

• Identify exceptions associated with validation protocol execution

Minimum Work Experience/Educational Requirements

• Bachelor’s Degree in Pharmacy or Engineering (Equipment Validation, Process Validation), Computer Systems, Information Technology (CSV), Life Sciences or equivalent experience

• Minimum of 10 years of pharmaceutical Validation experience is required

•In lieu of 10 years direct validation experience, will consider a combination of validation experience and progressive pharmaceutical experience with relevant experience in aseptic manufacturing, process engineering, or a quality role.

We are proud to be an EEO/AA employer M/F/D/V. We maintain a drug-free workplace and perform pre-employment substance abuse testing.