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

Additional requirements for this role

Equal Opportunity Employer

It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age, colour, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and / or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by applicable legislation or local law. In addition, Syngene will provide reasonable accommodations for qualified individuals with disabilities.

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