Job Description
Plan, manage & perform laboratory validation activities. Routine review of laboratory validation procedures & completed validation protocols for accuracy, completeness & maintenance of validated state per corporate requirements. Change control responsible for QC equipment. Collaboration & coordination with IT, metrology & other key stakeholders to ensure the right quality, cost & timely completion of all deliverables.
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Required Skills & Experience
• Bachelor’s Degree in Life Sciences, Chemistry, Engineering or a relevant field of study from an accredited university required
• Minimum of two (2) years of instrument, laboratory validation, or engineering experience in the pharmaceutical industry or related field required
• Experience in writing & executing validation protocols
• Experience in managing projects preferred
• Experience with electronic validation systems (TIMS) and SAP PM and QM module a plus
• Working knowledge of GMPs required
• Ability to act as project manager driving & implementing equipment projects required
• Demonstrated ability to write & present technical/scientific documents & reports preferred
• Understanding of QC equipment/systems, end user functionality & life-cycle management a plus
Benefit packages for this role will start on the 1st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.