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Pharmaceutical Sr. Process Engineer (Manufacturing Director)

Company: University of Iowa
Location: Iowa City
Posted on: August 16, 2019

Job Description:

The University of Iowa Pharmaceuticals (UIP) division of the College of Pharmacy seeks qualified applicants for a full-time Pharmaceutical Process Engineer in the Sterile Products department. This position will report to the Managing Director of UIP, and will support facility start-up and day to day operation of a sterile process manufacturing facility, optimizing processes and solving equipment issues. Areas of focus include process qualification and validation, formulation, filling & finishing. Study and provide techniques to improve existing process to minimize cost and increase efficiency. Lead all equipment related investigations for depyrogenation tunnels, mixing, filling, lyophilizing, finishing, etc. Support manufacturing equipment life cycle. The qualified candidate will contribute to developing improved and robust control strategies for manufacturing processes. Must have the ability to rely on experience and judgment to plan and accomplish goals with minimal supervision. The UIP is a Food and Drug Administration-registered pharmaceutical manufacturing facility, providing expertise in contract pharmaceutical development services to clients around the world. This is an exciting time to join UIP and sterile products in particular, as the unit will be moving to the new $96.3 million College of Pharmacy building scheduled to open in 2020. The lower level of this new building will be home to the UIP new sterile products manufacturing area which will be approximately 16,000 square feet and will increase UIP batch size capacity approximately 5-fold to 20,000 vials/batch. Key Areas of ResponsibilityLead start-up of sterile facility and process qualification of new manufacturing lines.Direct, schedule, and plan production activities. Oversee and provide expert technical advice and guidance in the administration and operational activities of a manufacturing unit in order to optimize manufacturing and safety procedures to achieve divisional goals. Perform engineering assignments as part of a larger project; evaluate processes or performance improvement projects for optimization. Recommend material and process specifications. Develop processes to achieve quality, cost, and efficiency requirements.Lead operational improvement teams, utilizing performance improvement methodologies such as Six Sigma, Lean, and 5S.Act as liaison with planning and design staff on operations and physical space design to ensure efficient processes for the introduction of a new services or space.Initiate, develop, and lead implementation process-related projects to achieve regulatory compliance, lower costs, and improve quality. Improve existing processes, lead team in evaluating new technologies, implement engineering changes, and establish new processes to align with cGMP.Facilitate and implement quality and operational improvement initiatives for unit, department or organization wide processes and projects to improve business productivity. Collaborate with business units to identify problems using metrics associated with Key Performance Indicators (KPI's) and recommend improvements to existing processes as needed. To Apply:Please attach a resume and cover letter and mark them as submission-relevant as part of the application process. Job openings are posted for a minimum of 14 calendar days. This job may be removed from posting and filled any time after the minimum posting period has ended. For questions or additional information, please contact Dennis Erb at . Successful candidates will be subject to a criminal and credential background check. Please note regarding references: Five professional references may be requested and required at a later step in the recruitment process. Moving and relocation reimbursements are negotiable within University policies. REQUIRED QUALIFICATIONSEducation RequirementM.S. in Engineering (preferably in Chemical, Mechanical or Biomedical Engineering) or equivalent. Experience RequiredMinimum 5-7 years related experience (in-house, co-op or acquired outside) in a pharmaceutical sterile processing GMP environment. This experience is evidenced by demonstration of knowledge and/or skills in areas such as: isolator filling technology, capping machines, depyrogenation tunnels, lyophilizers and aseptic processes; cGMP manufacturing, pharmaceutical production equipment including autoclaves, formulations tanks, CIP/SIP systems. Demonstrated ability to communicate effectively, orally and in writing including technical writing skills, to a variety of constituents internal and external to the organization.Possess knowledge of how to effectively run projects, coordinate contractors, and direct the activities of team members; have the ability to organize and present technical and project management overviews without assistance. Ability to perform effectively in multi-disciplinary teams. Leadership experience related to employee hiring, evaluation, and performance management.Demonstrated experience working effectively in a diverse environment.A valid driver's license, plus the ability to meet and maintain compliance with the University Driving Policy. DESIRABLE QUALIFICATIONSSterile facility start-up experience.Experience with Process Mapping and/or project management.Understanding of Six Sigma and Lean manufacturing (6S) methodology.Experience operating under design control and GMP manufacturing.Flexibility in work schedule. ******Equal opportunity/affirmative action employer The University of Iowa is an equal opportunity/affirmative action employer. All qualified applicants are encouraged to apply and will receive consideration for employment free from discrimination on the basis of race, creed, color, national origin, age, sex, pregnancy, sexual orientation, gender identity, genetic information, religion, associational preference, status as a qualified individual with a disability, or status as a protected veteran. Persons with disabilities who need assistance or accommodations with the application or interview process may contact University Human Resources/Faculty and Staff Disability Services, or . For jobs in UI Health care, please contact UI Health care Leave & Disability Administration at .

Keywords: University of Iowa, Iowa City , Pharmaceutical Sr. Process Engineer (Manufacturing Director), Healthcare , Iowa City, Iowa

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