Manager Process Engineer

Syngene International Limited • Baltimore, MD

107d

About The Position

Responsible for oversight of design, installation and ongoing troubleshooting of process equipment systems, controls and procedures used in pharmaceutical biologics manufacturing. Perform and oversee field engineering work to ensure quality, troubleshoot problems and drive results. Provide professional assistance and technical advice to support ongoing operations/manufacturing investigations through data analysis and team-based problem-solving methodologies.

Requirements

• A minimum of 8 years of experience in a biopharmaceutical or related environment in a project or construction management related role
• BS in Engineering, Science, Project/Program Management or equivalent experience
• ChE degree preferred
• Ability to think and act both strategically and tactically
• Highly effective verbal and written communicator at all levels of the organization
• Demonstrated ability to effectively prioritize and coordinate activities
• Proficiency in Microsoft Office applications
• OTJ experience with process design requirements for a pharmaceutical, biotech, or food industry (ISPE Baseline Guides, ISO and ASME BPE, EU/FDA Regulations for biological and drug products)
• Understanding of generation and distribution of high purity systems such as Water of Injection, CIP, Sterilization processes, Clean Steam, Clean Compressed Air

Nice To Haves

• Ability to organize/coordinate
• Comprehend and follow instructions
• Direct, control and plan
• Independently make quick decisions to solve complex issues
• Analyze/Interpret data and information
• Perform with frequent interruptions
• Make decisions using sound judgment
• Supervise/Manage others
• Regular and predictable attendance
• Use keyboard/computer/phone
• Ascend/Descend (climb), Move/Traverse, Reaching
• Work in multiple locations
• Work irregular hours that often include nights and weekends
• Work around extreme temperatures – cold or hot
• Work around noise above conversation level
• Ready to travel to other sites

Responsibilities

• Develop preliminary engineering drawings such as layouts, P&IDs and PFDs
• Prepare or review engineering calculations for analysis related to process design and equipment selection
• Act as project technical lead on highly complex projects, responsible for some project coordination activities
• Provide process engineering support in deviation investigations, CAPAs, and change controls
• Provide Engineering support for various types of process equipment: examples include bioreactors (Cytiva / ABEC technology preferred), TFF / filtration skids, Chromatography Skids and columns, single use mixers
• Analyze process data to support investigations and identify process improvements.
• Lead process risk assessments by applying standard project risk techniques and developing risk response plans with project team and stakeholders
• Lead procurement and vendor/contractor selection, constructability reviews, approval of submittals, field execution, commissioning protocol development and execution, and oversight and review of validation plan and regulatory submission strategy
• Influence other members of the Project Engineering and SME’s on project teams to drive continuous improvement, knowledge transfer, and professional growth of both you and your colleagues
• Identify areas to drive down project costs through lessons learned and develop specific improvement strategies to realize these savings
• Drive the complete execution of assigned projects in manner that drives high engagement from project team members

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Bachelor's degree
• Number of Employees: 5,001-10,000 employees