Associate Process Engineer
Associate Process Engineer
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Job Description
The Associate Process Engineer works with engineering facilities manufacturing operations and quality control staff to support University of Iowa Pharmaceuticals (UIP) facility and ongoing operations. This includes the day-to-day operation to optimize processes and solve equipment issues of sterile and non-sterile process manufacturing units. Major areas of focus include authoring and execution of equipment and process qualification and operation of control systems (SCADA Metasys etc.).
About the University of Iowa Pharmaceuticals
UI Pharmaceuticalsis a Contract Development and Manufacturing Organization (CDMO) within theCollege of Pharmacyat the University of Iowa. Our mission is toimprove quality of lifeby applying our pharmaceutical expertise to advance innovative products into clinical trials. Our vision is to be thepremier partner for biotech government and research institutions.
We are located on the main campus in Iowa City which offers a great place to live top rated schools a vibrant night life and world class health care facilities. As a University of Iowa employee you will have access to an excellent benefits package.
Key Areas of Responsibility
Analysis
- Support the Engineering and Manufacturing teams on multiple manufacturing lines.
- Support Engineering Facilities and Manufacturing by performing root cause analysis and troubleshoot facilities manufacturing process and equipment problems.
- Review and redline of Piping and Instrument Diagram during service validation and preventive maintenance and be able to document changes according to current Good Manufacturing Practices (cGMP).
- Collaboratively work with the Engineering and Production teams and vendors on required services and critical supplier-based replacement parts.
Engineering Project Management
- Responsible for projects at the department level that may have lasting impact at the organizational level.
- Maintain the engineering change control process and equipment assessments.
- Hands-on process improvement and validation for pharmaceutical process equipment.
- Validate the life cycle of equipment including authoring or review of validation master plans User Requirement Specifications (URSs) Factory Acceptance Testing (FAT) Site Acceptance Testing (SAT) Installation Qualification (IQ) Operational Qualification (OQ) Product Qualification (PQ) and engineering studies.
Compliance
- Review and evaluate completed work to determine if it meets all relevant specifications and regulations.
- Initiate implement or review new policies and programs that comply with Food and Drug Administration (FDA) requirements to ensure that current Good Manufacturing Practices (cGMP) regulations are met.
- Collaborate with Engineering and Quality Assurance to conduct GMP processes and other training for the new or current facilities and equipment.
- Initiate develop and implement process-related projects to achieve regulatory compliance lower costs and improve quality.
Planning
- Plan and develop project scope for locally controlled initiatives.
- Collaborate with Production and Quality Assurance on cross-functional projects to ensure timely and efficient use of staff and resources.
- Work with Engineering and Facilities on preventive maintenance (PM) reviews and implementation plans manage PM schedules and communicate with different areas i.e. Quality Assurance and Production teams on PM schedules and time frames for the execution of PM without impact on manufacturing.
- Manage equipment list and calibration schedule.
Application of Technical Knowledge
- Determine basic problem causes; develop recommendations for corrective action and follow-up to ensure completion of corrective action.
- Manage initiatives in off the shelf equipment SAT IQ OQ authoring and execution.
- Achieve Subject Matter Expert (SME) status for Supervisory Control and Data Acquisition (SCADA) Johnson Control and Metasys control systems oversee change control and lead validation activities when needed for these systems.
- Act as subject matter expert to perform training on the equipment and operation of the production lines.
Financial
- Assume responsibility for project and departmental budget compliance and assist in creating budget estimates for the same.
Leadership
- May provide functional and/or administrative supervision of staff.
- Provide direction assignments feedback coaching and guidance to coworkers to ensure project outcomes are achieved.
- Manage the successful completion of local scoped projects within budget on schedule and in compliance with engineering and regulatory requirements.
- Design evaluate and coordinate training of employees on new equipment and processes.
For a complete job description please contact Libby Kleppe at
Education Requirement
- B.S. in Engineering (chemical mechanical electrical etc.) with experience or knowledge in quality control.
Experience Required
- Minimum two years related experience in a pharmaceutical Good Manufacturing Practice (GMP) environment laboratory or biological environment. This experience is evidenced by a demonstration of knowledge and/or skills in areas such as isolator operation automated technologies environmental controls utilities (water for injection and clean steam) aseptic processes.
- Demonstrated ability to communicate effectively orally and in writing including technical writing skills to a variety of constituents internal and external to the organization.
- Strong writing skills in Standard Operating Procedures validation documents deviations investigations and batch records.
- Knowledge of pharmaceutical regulations Food and Drug Administration current Good Manufacturing Practice European Union International Society for Pharmaceutical Engineering etc.
- Ability to perform effectively in multi-disciplinary teams.
Desirable Qualifications
- Knowledge of qualification and operation of automated enclosures isolators or laboratory equipment.
- Pharmaceutical manufacturing or quality project-related experiences.
- Sterile facility start-up experience including validation cycles and cleaning validation of systems.
- Experience with process mapping and/or project management.
- Understanding of Six Sigma and Lean manufacturing (6S) methodology.
- Experience with Supervisory Control and Data Acquisition (SCADA) systems Metasys systems Johnson Controls International facility controls systems software PLC controls or automation controls.
Application and Position Details
- In order to be considered for an interview applicants must upload the following documents and mark them as a Relevant File to the submission:
- Resume
- Cover Letter
- 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. Successful candidates will be required to self-disclose any conviction history and will be subject to a criminal background check and credential/education verification. 5 professional references will be requested at a later step in the recruitment process. For additional questions please contact Libby Kleppe at
Benefits Highlights
- Regular salaried position.Pay level 4B. Located in Iowa City Iowa.
- Fringe benefit package including paid vacation; sick leave; health dental life and disability insurance options; and generous employer contributions into retirement plans.
- For more information about Why IowaClick here.
About Iowa
Joining the University of Iowa means becoming a vital part of the Hawkeye community where your work directly impacts education research and student success. Enjoy exceptional health coverage university-paid life insurance robust retirement plans and generous leave policies. Benefit from 24/7 support services well-being resources and access to UI Health Care specialists. Grow professionally with advanced training leadership development and tuition assistance. Iowa City offers a great quality of life with world-class performances at Hancher Auditorium Big Ten athletics top-ranked public schools and outdoor recreation. Join us in making a difference at a leading Big Ten university and premier public research institution.
Required Experience:
IC
Employment Type
Full Time
