Title:  Senior Validation Engineer, CSV

Job Title: Senior Validation Engineer 

Reporting to: Head – QA Validation 

Department: Quality 

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 

Manage and prioritize all phases of assigned validation projects from concept through validation of computer systems and ongoing support of cGMP operations.  They ensure cGMP regulatory compliance through adherence to site and corporate validation Plans, Policies, and Procedures and are in alignment with applicable GxP guidance and regulations, including GAMP5, 21 CFR Part 11 (US) and EU Annex 11.  Able to contribute at a high level in at least 2 of the following disciplines: Commissioning and Qualification, Computer Systems Validation, Validation Maintenance/Risk Management and Data Integrity.   

Primary Responsibilities: 

Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions. 

• Plan, Coordinate, and Execute assigned projects by effectively using Project Management methodologies 

• Reviews and approve validation related system lifecycle design documentation (user requirements, functional and design specifications, commissioning and qualification protocols) 

• Review, assess and approve (as applicable) CSV related materials for all site Computerized System projects 

• Perform hands-on field work for equipment and their associated control systems 

• Participate, as needed, in QA related audits of computerized systems, both internal and external. 

• Continually monitor the effectiveness of the CSV program, and recommend optimization opportunities as identified 

• Provide CSV guidance to the site and provide CSV education and awareness for corporate, as needed. 

• Act as a coach and mentor to other members of validation and project teams to drive continuous improvement, knowledge transfer, and professional growth of self as well as colleagues. 

• Identify areas to drive down project costs through lessons learned and develop specific improvement strategies to realize these savings.   

• Has wide-ranging experience, using professional concepts and company objectives to resolve complex issues in more efficient ways than lower levels. 

• Work on complex issues where analysis of situations/data require in-depth evaluation of variable, identified factors. 

• Exercises judgment normally in selecting methods, techniques, and evaluation criteria in resolving issues. 

• Determines own instructions and procedures on day-to-day tasks and new assignments. 

• Drive the complete execution of assigned projects in a manner that drives high engagement from project team members.    

The above statements are intended to describe the general nature of work performed by those in this job.  It is not an exhaustive list of all duties, and other duties may be assigned.  

Education & Qualifications: 

• A minimum of 8 years of experience in a biopharmaceutical or related environment in the area of CSV. 

• BS degree in Engineering, Science, Management, or equivalent experience  

• Demonstrated knowledge of cGMPs for biotechnology, validation-related topics, and key industry validation approaches (e.g., validation lifecycle approach, ASME BPE, PIC/S ISPE Baseline Guides ASTM E2500, GAMP 5, V-model, etc.). Complementary knowledge of biopharmaceutical and process engineering principles and practices. Working understanding of ICH Q7, Q8, Q9, Q10 and other international regulatory requirements is critical.  

• SME in at least two of the following, Commissioning and Qualification, Computer Systems Validation, Validation Maintenance/Risk Management and Data Integrity.  

• Ability to interpret regulatory rules, guidance, and normative industry standards to make objective, risk-based decisions, and exercise sound Quality-by-Design principles as they relate to validation issues. Experience presenting these outcomes to senior management.  

• Highly effective verbal and written communicator at all levels of the organization  

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.