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Computer Systems Validation Engineer - New Delhi, India - PSC Biotech
Description
Job DescriptionThe Computer Systems Validation Engineer (CSV) will be responsible for assisting in planning, writing, implementing, and reviewing validation protocols for computer-based systems.
The person is responsible for making sure computer-based systems are operating as intended and meet regulatory requirements.The incumbent is also responsible and accountable for the execution of the PSC mission, "to maintain the integrity and professionalism of our products and services while enabling steady growth and development.
"DUTIES AND RESPONSIBILITIES:
Write, review, and approve validation procedures, documents, test scripts and final reports in compliance with company policies and standards from regulatory agencies.
Keep up to date with advances in the field and the regulatory requirements.
Support involvement in review and updating of validation documentation.
Assist in reviewing and analysing validation data – compiling reports when required.
Recommendation of process upgrades and improvements in efficiency.
Support the implementation of such improvements with upper management.
Assist in involvement in both internal audits and external inspections as required.
Additional duties and responsibilities may be assigned from time to time.
Requirements
Bachelor's Degree in Computer Science or Engineering or equivalent experience.
2-5 years of experience in computer systems validation experience.
Demonstrated strategic thinking, implementation skills, and ability to drive results.
Strong attention to details.
Ability to follow protocols and procedures.
Excellent written and oral presentation and communication skills.
Highly organized in planning and time management, with the ability to multi-task.
Ability to work with team or independently.
Has experience writing, reviewing, and executing validation documentation, IQ, OQ, PQ, RTM, Test Scripts, Summary Reports.
Knowledge of operating systems and MS Office desired.
Knowledge of regulatory, compliance, and validation desired.
#LI-MS2RequirementsBachelor's Degree in a relevant science or engineering field, or equivalent hands-on experience. 3+ years of experience in the biotechnology and pharmaceutical industries with a minimum of 2 years of relevant experience performing CQV activities within GMP environment. Sound industry knowledge, project proficiency, and autonomy expected. Experienced in validation of facilities/utilities/equipment, including cleaning validation and IQ/OQ/PQ of equipment. Strong understanding of current risk-based validation approaches. Experienced in authoring, revising, reviewing, and completing controlled documents for validation projects. Experienced with risk assessments. Excellent organizational skills. High attention to detail. Strong written and verbal communication skills. Strong knowledge of the code of GMP and PIC/S code. Must be adaptable, customer service oriented, and have a positive attitude. #LI-MS2