DirecciónAbout Us:
Cognizant (Nasdaq: CTSH) engineers’ modern businesses. We help our clients modernize technology, reimagine processes and transform experiences so they can stay ahead in our fast-changing world. Together, we're improving everyday life. See how at www.cognizant.com or @cognizant.
Cognizant Technology Solutions is looking for “Empower Validation Lead” to join in our team of IT professionals in a permanent role. If you meet our background requirements and skills and are looking for an opportunity with these skills and expertise, here is the ideal opportunity for you!
Job Location:– Collegeville - PA (Onsite role).
Main Responsibilities and Accountabilities:
Design, modify, develop, write, review, and implement all Computer System Validation (CSV) documents, protocols, and reports for validation and qualification work. Typical validation deliverables include Validation Plans, System Risk Assessments, Traceability Matrices, Qualification protocols, and Validation Reports.
Execute all Execution Systems IQ and OQ protocols in coordination with Technical SMEs. Generate and track protocol discrepancy reports to closure.
Coordinates all CSV activities by constant communication with affected departments; oversees and reviews validation area processes and procedures; Review and approve computer system change controls, discrepancies, CAPAs
Ensures cGMP/Regulatory compliance with internal/external policies and, guidelines, including internal SOP’s, departmental standards and conventions.
Participate in the execution of gap assessment and remediation activities for the Data Integrity
Participate in assessing system reviews, deviations, CAPA, Changes, continuous improvement, and troubleshooting
Coordinate CSV/SDLC training and education
Minimum 8+ years’ experience with CSV methodologies in operation IT, OT, and Automation position with a good understanding of pharma, biotechnology, chemistry industries. Also experience in Empower system is preferred.
Demonstrated knowledge and experience with CSV regulations and SDLC guidelines for life-sciences and related best practices for compliance and risk-based approach.
Experience with Lab, Automation and computer validation methodologies.
Experience in writing, reviewing and executing CSV documentations (IQ, OQ, PQ)
Knowledge of industry standards related to computerized systems and Electronic Records/Electronic Signatures; 21 CFR Part 11, Annex 11, GAMP5 etc.
Working knowledge of software development lifecycle (SDLC) model and validation practices of various computerized systems
Proven ability to work within and contribute to a high performing team.
Self-motivated, demonstrates initiative, propensity to drive change
Detail oriented, with strong written and verbal communication skills.
Work Authorization:
Cognizant will only consider applicants for this position who are legally authorized to work in the United States.
Salary and Other Compensation:
The annual salary for this position depends on experience and other qualifications of the successful candidate.
Benefits:
Cognizant offers the following benefits for this position, subject to applicable eligibility requirements:
- Medical/Dental/Vision/Life Insurance
- Paid holidays plus Paid Time Off
- 401(k) plan and contributions
- Long-term/Short-term Disability
- Paid Parental Leave
- Employee Stock Purchase Plan
Disclaimer:
The salary, other compensation, and benefits information is accurate as of the date of this posting. Cognizant reserves the right to modify this information at any time, subject to applicable law.
Employee Status : Full Time Employee
Shift : Day Job
Travel : No
Job Posting : Feb 21 2024
About Cognizant
Cognizant (Nasdaq-100: CTSH) is one of the world's leading professional services companies, transforming clients' business, operating and technology models for the digital era. Our unique industry-based, consultative approach helps clients envision, build and run more innovative and efficient businesses. Headquartered in the U.S., Cognizant is ranked 185 on the Fortune 500 and is consistently listed among the most admired companies in the world. Learn how Cognizant helps clients lead with digital at www.cognizant.com or follow us @USJobsCognizant.Applicants may be required to attend interviews in person or by video conference. In addition, candidates may be required to present their current state or government issued ID during each interview.
Cognizant is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.
If you have a disability that requires a reasonable accommodation to search for a job opening or submit an application, please email CareersNA2@cognizant.com with your request and contact information.
