Manager Process Engineer

Job Title: Senior Process Engineer

Reporting to: Senior Facilities Manager

Department: Engineering, Facilities and Validation

About Syngene

Incorporated in 1993, Syngene International Ltd. is an innovation-focused global discovery, development and manufacturing organization providing integrated scientific services to the pharmaceutical, biotechnology, nutrition, animal health, consumer goods and specialty chemical industries around the world. Syngene' s clientele includes world leaders such as Bristol-Myers Squibb, Baxter, Amgen, GSK, Merck KGaA and Herbalife. Its innovative culture is driven by the passion of its 4240- strong team of scientists who work with clients from around the world to solve their scientific problems, improve R&D productivity, speed up time to market and lower the cost of innovation.

At Syngene, safety is at the heart of everything we do personally and professionally. Syngene has placed safety at par with business performance with shared responsibility and accountability, including following safety guidelines, procedures and SOPs, in letter and spirit.

Job Summary

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.

Primary 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
• Experienced professional with full understanding of work; resolves a wide range of issues in creative ways
• Work on problems of increasingly diverse scope; analysis of situation/data requires evaluation of identifiable factors
• Demonstrates good judgment in selecting methods and techniques for resolving issues and obtaining solutions
• Receives little instruction from supervisors, general instructions on new assignments
• Drive the complete execution of assigned projects in manner that drives high engagement from project team members

Education &

Qualifications:

• A skilled professional 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
• Technology/Equipment (DP/DS/Clinical/Commercial/SS/SU) emphasis will vary by site, candidate is expected to be able to guide site to top quartile operational safety, efficiency, and reliability for these technologies.
• 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

Additional requirements for this role:

• Ability to organize/coordinate
• Comprehend and follow instructions
• Direct, control and plan
• Independently make quick decisions to solve complex issues and solves problem
• 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,…