Manager, Process Engineering
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Job Location:
Philadelphia, PA - USA
Monthly Salary:
Not Disclosed
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
Overview
The Manager Process Engineering is responsible for ensuring that the equipment utilities and facility is designed installed start-up commissioned and operates as per specifications in addition to provide engineering support during validation. Incumbent will coordinate with the Facilities Engineering Validation Operations and Quality Control and Quality Assurance Teams to ensure maximum uptime and efficiency of all systems and equipment.
Specific Responsibilities
- Manage the Process Engineering team for a cell therapy manufacturing facility.
- Develop the scope of proposed future equipment projects for cost and schedule.
- Implement process improvements including the selection and modification of new equipment and facilities.
- Author review and edit technical documents including drafting and approval of Equipment Specification Test Protocols SOPs CAPAs Change Controls etc. Perform basic revisions as needed to accurately reflect current procedures. Review and edit documents created by other team members for accuracy clarity and consistency.
- Adheres to Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs) including Good Documentation Practices (GDP). Completes recording of data to comply with regulatory requirements.
- Ensure that all documentation is compliant with internal requirements regulatory requirements including FDA EMA and ISO standards.
- Attends regular management meeting to discuss timelines and priorities.
- Manage multiple projects to ensure timely initiation and completion of work.
- Maintain effective communication with project team members contractors and vendors.
- Liaison with the equipment and engineering vendors to support manufacturing and quality control.
- Create user requirements specifications for new projects.
- Training maintenance and operative staff when appropriate.
- Maintain our Engineering documentation and drawings.
- Oversee contractors when troubleshooting and professional repairs are necessary.
- Scheduling and Coordinating work in tight deadlines.
- Present our programs to agency auditors as required.
Education and Qualifications
- BS or MS in Engineering field is required or equivalent experience.
- 8 years of related BioPharma/Life Sciences experience required. Prior experience in cell therapy manufacturing is highly desirable.
- Has comprehensive understanding of principles theories concepts and industry practices and standards and their application.
- Extensive knowledge of small-scale cell culture processes and techniques is preferred.
- Experience interfacing with other design disciplines including automation facility design and mechanical design groups is required.
- Experience interfacing with CQV and operations teams is required.
- Experience in scheduling and budgeting Facilities & Process Engineering efforts is highly desirable.
- Demonstrable experience on cGMP capital continuous improvement and operating projects.
- Excellent oral and written communication skills required.
- Exceptional attention to detail and follow-through.
- Excellent verbal and written skills in communicating regulatory and technical information.
Physical Requirements
- Stand for long periods of time (2-4 hours).
- Lift up to 15 lbs.
- Sit for extended period of time in front of computer (2-4 hour).
#LI-onsite
The statements contained in this document are intended to describe the general nature and level of work being performed by a colleague assigned to this description. They are not intended to constitute a comprehensive list of functions duties or local variances. Management retains the discretion to add or to change the duties of the position at any time.
Iovance is committed to cultivating and offering a diverse and inclusive work environment. As an equal-opportunity employer our employees and applicants will be considered without regard to an individuals race color religion sex pregnancy national origin age physical and mental disability marital status sexual orientation gender identity gender expression genetic information military and veteran status and any other characteristic protected by applicable law. If you need assistance or accommodation to apply to one of our opportunities please contact .
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Required Experience:
Manager
Key Skills
- Hospitality Experience
- Go
- Management Experience
- React
- Redux
- Node.js
- AWS
- Mechanical Engineering
- Team Management
- Leadership Experience
- Mentoring
- Distributed Systems
About Company
Learn about our investigational tumor infiltrating lymphocyte (TIL) therapy and peripheral blood lymphocyte (PBL) therapy. View our clinical trials and pipeline.
