Position: Sr. Process Hybrid
Location: King of Prusia, PA (Hybrid)
Company: Sk Pharmteco
The Senior Process Engineer will be heavily involved in managing the manufacturing and production systems for cell and gene therapy operations. They will also be instrumental in engineering design, construction, and commissioning of capital and operational expansion projects at the Center for Breakthrough Medicines. They are responsible for development and implementation of process platforms that are well characterized, efficient, scalable, cost-effective and that produce high-quality products in GMP and development environments. This entails requirements gathering, specifications development, validation support, troubleshooting, quality standards compliance and identification of continuous improvement projects on production products and processes. The successful candidate will be able to collaborate with Manufacturing, Process Development, Quality, Facilities, Automation, and external parties. They will provide technical and subject matter expertise in facilities readiness assessments, facilities design and renovation projects.
Responsibilities:
Project Support:
- Manages Engineering responsibilities and reports progress to management for engineering testing, commissioning and qualification activities
- Responsible for all aspects of Engineering design and installation by working with external supply partners, design firms, and contractors.
- Ensures all project documentation is accurate and up-to-date (P&lDs, mechanical system drawings, automation documentation, etc.)
- Organize and leads technical aspects of large size operational and technology transfer projects including scope, schedule, and coordination of activities
- Compiles and Reviews of equipment Engineering Turnover Packages (EToPs) for executed projects
- Responsible for ensuring all equipment is walked down and revised for all types of engineering drawings
- Works with a cross-functional groups to develop requirements and recommendations for system/facility modifications
- Leads troubleshooting and remediation of exceptions found during process operations and technology transfers
- Accountable for all phases of the engineering lifecycle
- Defines all aspects of project scope and project activities
- Develop and Mentor junior engineers on Good Engineering Practices (GEP)
Operational Support
- Collaborates with manufacturing personnel regularly about standard practices and procedures for process and utilities equipment/automation design and operation
- Leads the technical support for SOP changes, Deviations, GMP Investigations and CAPAs
- Manages working relationships with process development, manufacturing, quality, facilities, procurement to proactively address process and performance problems
- On-call support as needed for all active process equipment and manufacturing activities
- Accountable for the timely resolutions of safety related design/equipment issues
- Own process equipment and single-use technologies for GMP manufacturing
- Re-engineer unit operations, equipment, and manufacturing areas to meet end-user's needs
- Accountable for troubleshooting activities, equipment design, and specifications for equipment (including single-use) and instrumentation
- Determine corrective maintenance actions, collaborates on preventative maintenance, works to identify spare parts for process and utility equipment
- Provides guidance to maintenance personnel and actively participates in the decision making and project execution of process and/or design improvement
- Owns and ensures timely closure of equipment corrective and preventative actions
Documentation, Standards and Templates
- Write, review and approve equipment specifications, engineering procedures and protocols
- Assist in the revision of manufacturing documentation (SOPs, BR, etc.)
- Comprehensive understanding of cGMPs
- Capable to defining department prioritization based on rapidly changing priorities and deadlines
- Capable of defining requirements based on industry practices, techniques, and standards
- Extensive biopharm process knowledge in at least one area: cell culture, fermentation & cell processing
- CAD/Bluebeam or other drawing editing capabilities
- EHS and Quality Minded
- Basic knowledge of Lean Principles Ability to Learn/Adapt
- Teamwork skills
- Independent problem solving skills
- Process flow/industrial flow
- Time management skills
- Effective communication skills
- Actively manage engineering drawings by coordinating and executing redlines, reviews, and revisions
Requirements:
- B.S. or M.S. in Engineering or a Life / Physical Science with relevant work experience (Chemical Engineering preferred, others considered)
- 5-8+ years experience investigating, developing, and implementing new manufacturing processes and improving existing manufacturing processes
- Working knowledge of design specification and operation of bioprocess equipment, clean utilities, GMP facilities, and automation.
- Owner of med-large process or portion of larger process with guidance from senior department leadership.
- Willing and able to execute hands-on, clean room manufacturing support where necessary.
