Cleaning Validation Supervisor - Cook Pharmica

Company Name:
Cook Medical
Cleaning Validation Supervisor - Cook Pharmica
Job Title: Cleaning Validation Supervisor - Cook Pharmica
Job Type: Full-Time
Location: Bloomington, IN
Minimum Experience Required: 01
Job Description:
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
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 support validation projects and coordinate the activities of the cleaning validation analytical testing relating to biopharmaceutical and pharmaceutical manufacturing equipment, manufacturing processes and laboratory documentation.
Essential Job Functions/Duties
o Coordinate multiple projects to provide documented validation of equipment, control systems, CGMP utilities and manufacturing processes
o Manage the activities of direct reports to accomplish scope of work of cleaning validation
o Analyze data associated with validation protocols
o Develop and review functional requirements specifications as related to process equipment
o Develop and/or review user requirement specifications
o Develop and review facility impact and component criticality assessments
o Develop validation protocols and associated summary reports
o Review facility change logs and provide input on revalidation activities
o Conduct enhanced design reviews for relevant process equipment
o Assess risks involved in processing steps and related to equipment
o Develop and review validation requirements and design deliver
Minimum Work Experience/Educational Requirements
o Bachelors Degree in Life Sciences, Chemical
or Mechanical Engineering or equivalent experience
o 1-2 years ofsupervisory, interpersonal, leadership and project management experience
o Possess excellent supervisory, interpersonal, leadership, project management skills
o Demonstrated ability to build, develop, lead and manage staff
o Strong understanding of Cleaning Validation of mammalian cell culture-based biopharmaceutical and parenteral pharmaceuticals.
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

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