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As an industry leader in providing validation and quality management systems to regulated industries, ValGenesis is constantly seeking talented, highly qualified, motivated individuals to join our team. If you are driven by the need to succeed, motivated by tremendous growth opportunities, and interested in working with cutting edge technology, we want to talk to you.
At the root of our success is our staff. Our employees are the best in the business at what they do and are awarded accordingly. As an employer, we offer our employees challenging and dynamic work in an innovative and highly rewarding work environment. If you feel as though you are the right fit for ValGenesis, please browse through our job listings to find the opportunity that is right for you. To apply for any position listed, contact us at hr@valgenesis.com and provide us with your resume and salary history information. We look forward to hearing from you.
Current Job Openings
Job Description
Position: Director Professional Services
Experience: Above 10 Years
Email: hr@valgenesis.com
Work Location: San Francisco, California, United States
The Director in ValGenesis’ Professional Services group will be responsible for managing the West Coast practice and coordinate the software implementation projects for our clients. Activities include team management, planning, resourcing and coordinating software projects for ValGenesis’ validation management software for Life Sciences companies, typically operating globally across multiple sites in North America, Europe and Asia. Directors Professional Services at ValGenesis are also hands-on team members providing various services such as strategic customer guidance, project management, business analysis and configuration support.
Required Skills:
- 10+ years of relevant team leadership and project management experience which includes managing of teams, projects, specifications, project milestones and associated deliverables
- 5+ years’ experience working in an FDA regulated organization and knowledge of the validation lifecycle process
- Transparent and professional reporting of practice and project status with in-depth analysis of potential challenges and risks
- Ability to develop and grow a business practice, including recruitment and team member development
- Excellent verbal and written communication skills
- Strong familiarity with ISO, GLP, GCP and other related regulatory standards and guidelines
- Demonstrated leadership of cross-functional project teams and an ability to drive project plans to completion
- PMP certification preferred
Benefits:
This is a full time position for an individual with at least 5 years of experience in a similar position. ValGenesis offers competitive compensation dependent on education and experience. ValGenesis benefits include a comprehensive health plan and additional insurance benefits (life, disability, etc.), bonus and Stock options. The company is a fast growing and dynamic organization with substantial opportunity for career growth and international travel
Job Description
Position: Global Sales Manager
Experience: 5+Years
Email: hr@valgenesis.com
Work Location: Tampa FL, San Francisco CA, Chicago IL, Dublin Ireland, Amsterdam NL.
Essential Functions:
- Direct major-account sales for ValGenesis products and services, while developing a credible, advisory relationship with targeted accounts
- Understand the goals and challenges of each account, specifically related to Validation Lifecycle Management
- Work closely with Marketing, Pre-Sales and Management to drive and manage the sales plan
- Identify, establish, report and maintain opportunity pipeline and forecast
Required Skills:
- 5 plus recent years selling complex application software solutions
- Background selling Enterprise Applications Sales to LifeScience companies required
- Clear understanding of the Sales process, product, and service value propositions
- Capability to leverage your relationships and your knowledge of the territory in which you are selling
- Consistent track record for developing new business and managing a complex sales cycle, from generating leads to closing deals
- Successful track record of management of ongoing client relationships
- Experience with QMS, ECM, Validation and PLM solutions a plus
- Highly motivated professional with excellent communication and interpersonal skills
- Excellent written and verbal communication skills
- Able to work independently in a fast-paced environment
- Knowledge of Zoho or other CRM systems
Education:
- Bachelors degree (BA or BS)
Job Description
Position: Pre-sales/ Industry Solution Engineer
Experience: 5+Years
Email: hr@valgenesis.com
Work Location: San Francisco CA, Tampa FL, Boston MA, Amsterdam NL.
Essential Functions:
- Work with the Sales team by being the industry consultant and a product expert who understands, demonstrates and positions ValGenesis solutions, “linking” the key values of the solutions to the primary business needs and drivers in each opportunity from RFP through demonstration stages of the sales cycle.
- Understanding of and participation in the complex sales environment
- Knowledge of the LifeScience industry, current business drivers, and the ongoing governing regulations
- Outstanding presentation skills and “presence” in reading and managing an audience
- Ability to work in a collaborative environment (product management, sales, marketing) and provide relevant feedback from customers and prospects
- Conduct competitive landscape analysis to understand current competitor solutions and potential future strategy
Required Skills:
- 5 plus recent years of working as a validation engineer in the LifeScience industry
- Experience in using automated tools for managing the validation lifecycle process
- Knowledge in the regulations related to the validation process in LifeScience industry
- Strong oral and written communication skills
- Proficiency with MS Office tools
- Fluency in European languages a plus
Education:
- Bachelors degree (BA or BS)
Job Description
Position: Validation Manager with CSV experience
Experience: 10+Years
Email: hr@valgenesis.com
Work Location: Chennai
Required Skills:
- Knowledge and experience in Computer system validation, 21 CFR part 11 compliance requirements, electronic data and electronic signatures
- Strong understanding of ICH, GAMP guidelines requirements in Life Science
- Knowledge on Quality Management Systems
- Experience of leading/ driving validation projects involving review of Computer Systems, Root cause Investigation, CAPA
- Shall responsible for preparation and review of validation/ qualification document related to GxP impacting computerized systems
- Experience in the review of Validation Deliverables (Project Documentation)
- Experience with Technical Document writing (SOPs) and development
- Risk-based approach to compliant GxP computerized systems
- Experience of working with Pharma/ BioTechnology/ CRO organizations
- Should have experience in guiding the team on pharma regulations & compliances
- Conduct periodic internal reviews or audits to ensure that compliance procedures are followed
- Conduct or direct the internal investigation of compliance issues
- Should bring in checkpoints at every phase of the project to ensure review of deliverables to the client
- Should bring in expertise of coming up with self & peer review checklist
- Assess product, compliance, or operational risks and develop risk management strategies
- Evaluate testing procedures to meet the specifications
- To prepare the project plan and initiate subsequent actions w.r.t. GxP computerized systems validation activities
- Ensure the necessary validation documentation is completed in alignment with the CSV SOP and policies before release of the GxP computerized systems to users
Job Description
Position: Pre-Sales Manager
Experience: 5 – 10 Years
Email: hr@valgenesis.com
Work Location: Mumbai
Roles and Responsibilities:
- Pharma domain consultant with expertise in Validation of enterprise wide Quality IT systems using established Computer System Validation (CSV) methodology such as GAMP 5 and FDA guidelines. Hands on experience in any one type of validation, Cleaning, Process and Method is a must
- Strong background in FDA, ISO and EU regulations for medical devices and healthcare; especially FDA 21CFR Part 820/Part 11, ISO 13485 and EU Annex 1
- Bachelor’s degree in Pharma/Engg; Advanced degrees in Quality, Regulatory will be an additional advantage
- 5+ years of consistent experience in IT Software Validation methodology in regulated medical device, pharmaceutical and healthcare industry
- Managing RFPs, RFI and proposals end to end. Effectively engage in a variety of client interactions including solution presentations, and demonstrations
- Ability to multi task and work under tight deadlines. Key Responsibilities
- Understand the business problems/challenges faced by the Pharma industry and articulate our offerings to the prospective client
- Configure and demonstrate the Company product and share our value proposition with the prospective clients
- Clearly articulate the business problem or business challenge faced by the Clients to the internal business Analysts, Delivery and technology teams to enable them to arrive at a suitable solution to fit the functional, technical requirement
- Ability to develop and deliver the proposal best suited for the requirement, and re-work the existing proposal content if required
- Build /customize Case Studies, email brochures etc. with assistance from technical and professional services team
Required Skills:
- Excellent written and verbal communication skills
- Excellent presentation skills
- Must have worked in Pharma industry handling Validation
- Excellent abilities in MS Office (Excel, Word, PowerPoint and Visio). Experience working in MS Project is a plus
- Strong time management and prioritization skills
Job Description
Position: Data base Administrator
Experience: 5 – 10 Years
Email: hr@valgenesis.com
Work Location: Chennai
Required Skills:
- SQL Server Database Administration
- Skilled in architecting structure of system to optimize performance
- Experience in SQL Server administration native tools
- Disaster recovery planning experience
- SQL Programming skills
- Improve SQL Query performance
- Ability to analyze and debug Stored Procedures
Job Description
Position: Business Analyst (Validation)
Experience: 5 – 10 Years
Educational Qualification: Bachelor’s degree in Engineering or science or related field as a minimum (Chemical/ Biotech/ Pharmaceutical/ Food Processing)
Email: hr@valgenesis.com
Work Location: Chennai
Roles and Responsibilities:
- Responsible for the Testing, Implementation & Support of the Validation System
- Demonstrate expertise in at least one aspect of system qualification and regulatory compliance (e.g., EMEA, GCP, GLP, GMP, QSR, ERES) and internal requirements employing regulatory guidance and industry standards
- Work independently on and successfully solve problems and complete/qualify a system within given constraint of scope, time and schedule
- Solid understanding in process & cleaning validation and application of GMP with emphasis on the application of Change Control practices
- Working knowledge of the development of protocols for the Validation of complex computer systems (e.g., multiple GAMP classes of systems); Protocol development will include ability to develop Installation, Operational and Performance qualification documents
- Lead system qualification efforts and be the primary client contact for coordinating work, reporting status, resolving issues, and addressing change orders as they apply
- 5 – 10 years of experience in Process / Cleaning / Analytical Method / Computer System validation experience
- Experience in Pharma / Life Sciences (API / Formulations) Manufacturing Process
- Experience in Project execution within at least one area of systems validation – e.g., laboratory equipment, facilities utilities, manufacturing equipment, metrology equipment, information systems
- Ability to understand & execute protocols including complex systems such as process validation, computer controlled systems validation, complex utilities and manufacturing equipment such as computer controlled filling systems, formulation systems and basis knowledge of laboratory validation
- Must have strong attention to detail
- Must have strong technical writing skills
- Proficient in Microsoft Word, Excel, Power Point and Project
- Ability to plan and manage own work
- Ability to interact with clients in professional manner
- Fluent in English, spoken and written
- Willing to travel regionally and/or nationally throughout the India
Job Description
Position: Senior Validation Engineers with CSV experience
Experience: 4+Years
Email: hr@valgenesis.com
Work Location: Chennai
Required Skills:
- To ensure Validation and Compliance of IT systems installed in GxP areas
- To plan, co-ordinate and review the Validation, Re-Validation and Qualification of GxP Computerized Systems as per CSV Manual
- To assist the process owners in validation of IT systems as per the CSV manual
- To author, review and implement IT related SOPs at manufacturing location
- To author & review the Software Validation documents (like :URS, DS, FS, IQ, OQ, PQ, SRS, RTM, GxP Assessment, Risk Assessment (Protocol-Report),Vendor Assessment, VSR, SRC and VDL of GxP systems
- To impart functional training, identify training needs and maintain training records
- To assist QA, Compliance & IT in internal audits pertaining to IT related activities at site
- To raise & review deviations comes under purview of IT and participate in investigation
- To raise & review Change Control comes under purview of IT
- To involve in internal audits and self-inspections as a team member
- To assist in audit preparation for internal and external audits at various sites
Job Description
Position: Software Engineer/ Sr. Software Engineer/ Module Lead
Experience: 5 – 10 Years
Educational Qualification: BE / BTech in Computer Science/ MCA
Email: hr@valgenesis.com
Work Location: Chennai
Required Skills:
- ASP.NET with C# | Dot Net Framework 4.0 and above | SQL SERVER 2008 and above
- Experience in MVC Pattern
- Experience in Web Services, WCF, LINQ, Ajax, Load Balance and Web API
- Knowledge/Experience in SSO integration using LDAP, ADFS, OKTA, PING
- Knowledge/Experience in XSS, SSL, TLS, OWSAP standards
- Knowledge/Experience in Xaml, WPF, CSS, Bootstrap
- Knowledge/Experience in Scripting: Java Scripting, JQuery, AngularJS
- Knowledge/Experience in HTML, HTML5, XML , OOXML
- Knowledge in Serializations Jason is an advantage
- Knowledge/Experience in using TFS / SVN
- Knowledge/Experience in DevExpress report, SSRS, crystal report, BI Components
- Knowledge/Experience using 3rd party Control: Infragistic, Far Point
- Experience with Web Server IIS 7.0 and above is required
- Knowledge/Experience in VSTS, QTP is preferable
- Experience writing SQL queries and interpreting query execution plans
- Knowledge in Agile Methodology
- Good Oral and written communication skills
Job Description
Position: Database Manager / Architect
Experience: 8 – 13 Years
Educational Qualification: BE/B.Tech Computers, MCA
Email: hr@valgenesis.com
Work Location: Chennai
Proficient in design and development of relational (& optionally hierarchical) databases, including ability to design for performance, scalability, availability, flexibility & extensibility, meeting security requirements.
- SSIS and data integration tools.
- Strong troubleshooting, performance tuning skills and writing & fine-tuning stored procedures.
- Data Archival Strategy, Architecture Design and Implementation.
- Develop and implement strategy for data archival at application/ module level.
- Experience as a database administrator developing and supporting large OLTP enterprise systems.
- Proven enterprise database administration experience in SQL server.
- Working knowledge of database engineering activities, including installation and configuration of SQL Server 2014 and later versions.
- Proficient in High Availability concepts including database recovery procedures, HA design and effective disaster recovery planning.
- Provide innovative solutions using emerging technologies/azure.
- Strong problem solving, analytical and diagnostic skills.
- Experience of best practices for efficient database access.
- Excellent written and verbal skills.
- Experience in SQL server Filestream.
Required Skills:
- Must know SQL server 2014 and later versions.
- Must have minimum of 8 years experience specifically in SQL /SSIS development.
- Must have strong hands on experience in development, implementation and deployment of multiple data base integration-based projects.
- Hands on experience in C# and ASP.NET.
Job Description
Position: Performance Test Engineer
Experience: 4 – 8 Years
Educational Qualification: BE/B.Tech Computers, MCA
Email: hr@valgenesis.com
Work Location: Chennai
The performance engineer works closely with development team to ensure our applications perform well under load. That means writing and executing scripts, monitoring the performance of the load testing hardware under load, analyzing and reporting the results, analyzing performance bottleneck and working with the right people to resolve issues.
The performance engineer will also have to ensure the client-side performance is up to par in a variety of supported browsers so they should have a good understanding of technologies like Java script and Ajax, and be able to identify slow page elements.
Required Skills:
Performance Engineer is primarily responsible for load testing, conducting performance analysis, benchmarking and also provide feedback and performance recommendation to product development. Based on design and requirements documents, the performance engineer will identify and collect the necessary metrics to ensure the performance, stability, and scalability of Informatica’s products.
- Design and develop performance test plans, test cases based upon requirements and Customer/Field use cases.
- Design, develop and maintain internal and external Performance Benchmarks.
- Conduct performance analysis findings to product teams and leads.
- Work closely with the development teams to analyze the performance issues, debug and resolve any issues.
- Participate in product functional reviews, test specifications, documentation review.
- Collaborate effectively with peer engineers and architects to solve complex problems spanning their respective areas to deliver end-to-end performance quality in our technology and customer experience.
- Understand business use cases, internal/external performance Benchmarks, debugging performance issues, decision making on issues, technical assistance in performance analysis and tuning DB/OS etc.
- Influences development managers to ensure appropriate levels of Performance quality on owned technologies.
- Minimum 3 years experience with JMeter or Neotys or VSTS load testing is required.
- A deep understanding of performance testing methodologies, like Performance Testing Guidelines for Web and .NET Applications.
- Experience in performance analysis at different layer such as Database tuning, and UI tuning.
- Experience with performance monitoring tools and understanding performance metrics.
- Execute and live performance tests on a daily basis.
- Should have strong Analytical and Technical problem-solving skills.
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