Associate Computer Systems Validation (CSV) Specialist - Brooksource Elevate Program
Position Overview: Join Brooksource's Elevate Program as an Associate Computer Systems Validation (CSV) Specialist, offering technical and professional development opportunities during a contract period with a leading pharmaceutical manufacturer. This role involves supporting computer systems validation activities, ensuring compliance with regulatory standards, and maintaining data integrity.
Responsibilities:
- Assist in the support of computer systems validation activities, including reviewing and approving documentation for the validation/qualification of non-GMP and GMP systems.
- Provide input for the risk management approach for CSV at designated sites.
- Support internal and external CSV-related audits and privacy-related inspections, collaborating with Computer Systems Quality Assurance on GMP-related systems.
- Help maintain Data Integrity readiness for regulatory authority inspections at designated sites and assist in representing the company during regulatory audits.
- Identify opportunities for leveraging technology to enhance business effectiveness.
- Assist in maintaining the organization's System Development Life Cycle (SDLC), ensuring adherence to business and regulatory requirements.
- Collect and evaluate data to improve compliance, privacy, and SDLC-related policies. Assist in developing plans for continuous quality improvement.
- Participate in business planning activities and governance and steering teams.
- Support the determination of GMP designation and testing requirements for analytics tools.
- Ensure compatibility, integration, interoperability, stability, scalability, and usability of implemented products/services.
- Consider security and privacy risks in the design and testing of IT systems.
Basic Qualifications:
- Bachelor’s Degree in Information Systems, Computer Science, Programming, or Engineering (Computer, Electrical, Industrial, Mechanical, Chemical) or equivalent.
Additional Preferences:
- Some experience or coursework in a regulated industry (e.g., GMP) with a basic understanding of IT quality processes related to manufacturing and distribution.
- Effective written and verbal communication skills in English.
- Ability to assist in writing technical documents, developing business presentations, and communicating concepts to various personnel.
- Willingness to collaborate with colleagues at all levels and demonstrate integrity.
- Ability to take initiative, work independently, and be adaptable to changing priorities and requirements.
- Basic understanding of cGMPs, processes, production practices, and quality systems.
- Willingness to learn and apply standards to different situations, with good problem-solving skills.
- Basic knowledge of regulations governing CSV and data integrity.
- Willingness to speak up with ideas and concerns, ensuring psychological safety for others.
- Learning agility and the ability to think creatively.
- Business acumen with the ability to communicate with executives, stakeholders, and technical staff.
- Basic understanding of system integration, including interface design and web-oriented architecture techniques.
- Familiarity with common information architecture frameworks and information models.
