Validation Engineer, Infrastructure Specialist
19 hours ago
Job Summary:
We are seeking a highly skilled Validation Engineer, Infrastructure Specialist to join our team at IT Solutions LLC. As a key member of our infrastructure team, you will be responsible for performing validation of computer systems, process automation, equipment, utility systems, and/or facilities.
Key Responsibilities:
- Execute test plans according to approved procedures, collect samples, tabulate test results, and organize data packages.
- Compile and analyze validation data, prepare reports, and make recommendations for changes and/or improvements.
- Investigate and troubleshoot problems that occur and determine solutions.
- Coordinate and execute validation change control and preparation of draft protocols, reports, and data tables.
- Maintain all documentation pertaining to validation.
- Assist in developing procedures and/or protocols.
- Coordinate contract personnel through completion of assignments.
- Participate on cross-functional project teams with the support of Development, Manufacturing, Engineering, Quality, and other groups as required.
Requirements:
- 8+ years of experience in validation principles, concepts, practices, and standards.
- Working knowledge of current Good Manufacturing Practices (GMPs).
- Previous experience with Computer System Validation (CSV) and experience with System Development Life Cycle of automated computer systems within biopharmaceutical environments.
- 6+ years qualifying infrastructure and OT networks.
- Working knowledge of validation of process control (PCS) and data acquisition systems is preferred.
- Strong verbal, written, and interpersonal communication skills.
- Proficient in Microsoft Office applications.
What We Offer:
Eligible W2 employees receive a comprehensive and highly competitive benefits package. IT Solutions LLC provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.
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