CSV Labs Engineer

We are actively seeking a proficient and motivated CSV Labs Engineer with a specialized focus on Laboratory Information Management Systems (LIMS) to join our esteemed team at CSV Labs. In this pivotal role, you will be instrumental in ensuring the robust validation, compliance, and efficient operation of computerized systems, particularly those integrated with LIMS.

Responsibilities:

1. Develop, review, and execute validation protocols (IQ, OQ, PQ) for CSV Labs automation systems, placing emphasis on precision in PLC, HMI, SCADA, and integrated LIMS systems.
2. Author, review, and execute CSV documents, including Validation Plans, URS, FRS, and traceability matrices, ensuring alignment with regulatory standards and LIMS requirements.
3. Manage and execute CSV deliverables for CSV Labs automation systems, strictly adhering to regulatory requirements such as 21 CFR Part 11, Annex 11, and GAMP5, with a particular focus on LIMS compliance.
4. Develop and maintain CSV standard operating procedures (SOPs) tailored to the unique requirements of CSV Labs automation systems, including LIMS integration.
5. Collaborate seamlessly with cross-functional teams to ensure the timely and budget-conscious implementation and validation of CSV Labs automation systems, especially those interfacing with LIMS.
6. Actively participate in risk assessments, change control processes, and deviation investigations related to CSV Labs automation systems, with a keen understanding of LIMS impact.
7. Provide steadfast support for the ongoing maintenance and re-validation of CSV Labs automation systems, with a specific focus on the LIMS component.
8. Offer technical expertise and guidance to other departments, addressing CSV-related issues and inquiries, particularly those related to LIMS integration.

Qualifications:

1. Bachelor's degree in engineering, computer science, or a related field.
2. Minimum of 5 years of hands-on experience in computer system validation within the pharmaceutical or biotech industry.
3. Essential experience with CSV Labs automation systems, with a strong focus on LIMS integration.
4. In-depth knowledge of 21 CFR Part 11, Annex 11, and GAMP5 is mandatory, with specific expertise in LIMS regulatory requirements.
5. Proficiency in creating and executing validation protocols (IQ, OQ, PQ) and CSV documents (Validation Plans, URS, FRS, and traceability matrix), especially those applicable to LIMS.
6. Outstanding communication and interpersonal skills to facilitate collaboration across diverse teams.
7. Strong problem-solving abilities and meticulous attention to detail.
8. Demonstrated ability to work independently and collaboratively in a team-oriented environment.