CSV Engineer

We are #hiring for below position:

Position: CSV Engineer

Responsibilities:

· Author, Review, Approve and Execute CSV life cycle documentation.

· Develop and execute validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), for computerized systems.

· Conduct risk assessments and impact analyses to identify and mitigate potential compliance issues.

· Collaborate with IT, Quality Assurance, and other stakeholders to define user requirements and system specifications.

· Perform periodic reviews and audits to ensure ongoing compliance with regulatory requirements and internal standards.

· Provide technical expertise and guidance on CSV principles, best practices, and industry trends.

· Participate in validation projects from planning through execution, ensuring timely completion and documentation of validation activities.

· Maintain accurate records and documentation in accordance with regulatory guidelines and company policies.

Qualifications and Skills:

· Bachelor's degree in Computer Science, Information Technology, Engineering, or related field.

· Previous experience in CSV, preferably in the pharmaceutical or healthcare industry.

· Strong understanding of regulatory requirements, including FDA 21 CFR Part 11, EU Annex 11, and GxP guidelines.

· Experience developing and executing validation protocols for computerized systems.

· Hands on experience in Implementation & Validation of various computerized systems like PCS (DeltaV) / BAS (Rockwell) / MES (Syncade) and Pi Historian / SCADA / PLC

· Strong knowledge of Software Development Lifecycle (SDLC), including 21CFR part 11/Annex 11, Data Integrity and computerized system validation requirements.

· Proficiency with validation tools and methodologies, such as GAMP 5 and risk-based validation.

· Experience working with and programming/commissioning/validating Delta V software platforms.

· Experienced at working independently as well as in a team-oriented, collaborative environment is essential.

· Excellent communication skills, with the ability to effectively collaborate with cross-functional teams.

· Detail-oriented with strong analytical and problem-solving skills.

· Ability to work independently and manage multiple projects simultaneously.

Benefits:

· Competitive salary and benefits package.

· Opportunities for professional development and training.

· Exposure to cutting-edge technologies and projects.

· Collaborative and supportive team culture.

· H1B Processing (EMPLOYMENT SPONSORSHIP AVAILABLE)

· Contract to PERM role

Candidate MUST BE Authorized to work in the United States

OPT / STEM OPT / H1 / H4 EAD / GC / USC all welcomed to apply

We Won’t work on C2C for GC and USC

Please apply with your updated resume if you are interested.