Provides leadership in managing behavior relative to policy, procedures and functionally assigned tasks.
Participate in the protection of the facility and physical assets of the plant.
Drive work practices, policies and procedures that support meeting or exceeding safety, quality and production goals.
Develops and maintains interdepartmental and intradepartmental relationships to effectively work with all functional areas.
Support the development and implementation of NPD’s. Identify issues that prevent scale up of new formulations
Organize and lead industrial trials as required during the technology transfer process. Both on site and at co-packer facilities.
Participate in and drive continuous improvement projects.
Assures compliance with all cGMPs.
Liaises with process development, technical service, operations, maintenance, engineering, and planning to ensure expeditious validation/qualification of equipment, process improvements, and new processes/products introduced into the plant.
Manages interaction with governmental agencies and customers, as required.
Participates in the coordination and implementation of the capital planning projects from a process engineering / validation perspective.
Drives root cause analysis for failures and implements all corrective and preventative actions
Effectively applies knowledge of FDA, MHRA, and DEA guidelines.
Support the overall validation and compliance efforts for the Salt Lake site. Generating and executing protocols, such as Installation, Operational, and Performance Qualifications (IOPQs), Process Validations (PVs) and Cleaning Validations (CVs).
Assists in the development, improvement and implementation of the Salt Lake validation master plan.
Ensure that the elements or functions that are regulated by the cGMPs for equipment, facilities, computer systems, manufacturing processes and packaging processes meet the regulatory requirements.
Support the site change management process by assessing the impact of changes on the validation status of the equipment.
Generate or revise procedures.
The experience we're looking for
Must have a Bachelor’s degree in a scientific field such as, but not limited to, Chemical Engineering, Computer Science/Information Technology, Chemistry, Biology, or Biochemistry, or at least six years’ experience in Process Engineering, Validation, Quality Assurance or Quality Control in an FDA regulated manufacturing or processing environment.
Must have a minimum of 6 years of professional experience
Ability to work over eight hours a day when needed.
Computer Literacy, especially with the Microsoft Office Suite products.
Strong communication skills in both a written and verbal manner
Superior ability to analyze data and generate conclusions based upon the data
Excellent interpersonal and problem solving skills in dynamic environment.
Strong organizational skills.
Strong capability in the use of statistical tools to develop sampling plans.
Ability to manage multiple priorities within established project deadlines.
Ability to work/crawl in confined spaces.
Ability to stand, stoop, bend, sit for long periods of time.
Ability to work in an environment that requires a respirator.