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Validation Engineer for Computer Systems
2 months ago
Position Overview:
The Computer Systems Validation Engineer (CSV) plays a crucial role in ensuring that computer-based systems function correctly and adhere to industry regulations. This position is vital for upholding the integrity and professionalism of the services offered by PSC Biotech.
Key Responsibilities:
- Develop, assess, and endorse validation protocols, documentation, test scripts, and final reports in alignment with organizational policies and regulatory standards.
- Maintain precise validation records and documentation.
- Stay informed about advancements in the field and evolving regulatory requirements.
- Participate in the review and enhancement of validation documentation.
- Analyze validation data and compile reports as necessary.
- Propose enhancements to processes and efficiency improvements.
- Collaborate with management to implement recommended improvements.
- Engage in internal audits and external inspections as required.
- Additional responsibilities may be assigned as needed.
Qualifications:
- Bachelor's Degree in Computer Science, Engineering, or a related field, or equivalent experience.
- 2-5 years of experience in the field of computer systems validation.
- Proven ability to think strategically, implement solutions, and achieve results.
- Meticulous attention to detail.
- Ability to adhere to established protocols and procedures.
- Exceptional written and verbal communication skills.
- Strong organizational skills with effective time management and multitasking abilities.
- Capability to work collaboratively or independently.
- Experience in writing, reviewing, and executing validation documentation, including IQ, OQ, PQ, RTM, Test Scripts, and Summary Reports.
- Familiarity with operating systems and MS Office is preferred.
- Understanding of regulatory compliance and validation processes is advantageous.
This position is offered as a contract role.
