Title:  Senior Validation Engineer, EUF

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 performance qualification and ongoing support of cGMP operations.  They ensure cGMP regulatory compliance through adherence to site and corporate validation Plans, Policies, and Procedures.  Able to contribute at a high level in at least two of the following disciplines: Commissioning and Qualification, Sterility Assurance, Cleaning Validation, Computer Systems Validation, Validation Maintenance/Risk Management, and Application of Statistical Technique.  

Primary Responsibilities: 

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

• Possesses strong knowledge of validation and related practices, including governmental regulations 

• 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) 

• Perform hands on field work for equipment, aseptic processing, steam sterilization, and cleaning validation and their associated control systems 

• Uses proven monitoring and problem-solving techniques such as SPC and DMAIC 

• Provide customer focus supporting engineering, research and development, quality, manufacturing sciences and technology, and manufacturing as a Subject Matter Expert and leader within the Validation department 

• Solves a range of varied and complex problems requiring analysis/interpretation and are solved using knowledge/skills, precedents, and practices. These include but not limited to process troubleshooting, operations support, root cause analysis, and risk assessment to document and accept risk 

• 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 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 system qualification or validation 

• BS in Engineering, Science, Project/Program Management 

• 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 compliance 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 and validation specific software programs 

• Strong problem-solving and critical thinking skills with demonstrated ability to conduct technical programs and to achieve program goals; strong organization skills to handle and delegate multiple projects at differing levels of complexity 

• Possesses strong knowledge of current validation best practices, including governmental regulations and GxPs.   

• Subject Matter Expertise in two of the following Validation disciplines: Commissioning and Qualification, Sterility Assurance, Cleaning Validation, Computer Systems Validation, Validation Maintenance/Risk Management, and Application of Statistical Technique 
  

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.