CSV Specialist

at  Weil Group Inc

The resources for this opportunity must meet the following minimum requirements in order to be considered:

• Bachelor’s degree in engineering or science.

• Training in validation methodologies, technologies and process control computer systems.
• Five (5) years of experience in computerized system validation of pharmaceutical or biopharmaceutical industry.
• Incumbent need to decide regarding the design and execution of compliant and efficient validation strategies for system and equipment supporting the Client’s Site.
• Incumbent has to continue the development of a technically competent and focused customer services-oriented team.
• Ensure that timely and adequate computerized system validation is performed in conformance with cGMP’s plant procedures, corporate policies, and applicable regulations (FDA, ENEA, DEA, etc)
• Prioritizes projects and schedules as needed.
• Provides guidance for determining work procedures, preparation of work schedule, and expediting of workflow.
• Enforce periodic reviews audits in accordance with Client policies and guidance
• Knowledge of laboratory instruments operations and background in pharmaceutical products manufacturing environment.
• Strong knowledge of relevant GMP, FDA, 21 CFR Part 11 and Data Integrity Regulations (Risk Assessment, Data Mapping etc), EU regulations and the ability to interpret and apply them for intended use.
• Knowledge with network communications protocol (i.e. TCP/IP)
• Knowledge in Computerized System Validations.
• Acquainted with GAMP5 methodology for validations.
• Good skills revising validation/commissioning, and technical documentation in English and using MS Office applications.
• Fully bilingual (Spanish/English) communication skills, both written and verbal.
• Self-motivated, creative and teamwork oriented
• Technical and scientific capability to make firm decisions and recommendations.
• Excellent interpersonal skills and the ability to interact with people at all levels
• Effective communication Skills
• Sense of urgency and analytical thinking
• Proficient knowledge of computer systems (Microsoft Office etc.) with data collection software (database) and applications like Infinity and SAP
• Solid ability for analyzing data detecting deviations, inconsistencies and interpret sampling test results
• Proficient knowledge of problem solving and root cause analysis methodologies (i.e. Kepner Tregoe)
• Willing to work irregular hours, rotative shifts, weekends and holidays when needed.

**Weil Group is proud to be an Equal Employment Opportunity Employer.

Please refer the Job description for details