Validation Specialist / Engineer

Job Description

We are seeking for talented, dedicated individuals who is committed to work under the highest standards of ethics to and with expertise in the following areas:

• Computer System Validation (CSV)

• Cleaning Validation
• Manufacturing, Packaging and Laboratory Equipment     
• Commissioning / Qualification
• Quality Engineering in Medical Devices
• Quality Manufacturing in Medical Devices
• Process Validation
• Project Management
• Quality Control / Assurance

Qualifications

• Bachelor's Degree in Science and Engineering
• Minimum of 3+ years of experience in direct pharmaceutical, medical device or biotechnology industries.
• Experience in direct process / manufacturing areas.
• Must be fully bilingual (English / Spanish) with excellent oral and technical writing skills.
• Must be proficient using MS Windows and Microsoft Office applications.
• Strong knowledge in cGxP and regulatory guidance as well as understanding of how they are applied to regulatory compliance, i.e. FDA guidelines, cGMP, 820, OSHA, 21 CFR Part 11, and other related CFR's, ISPE Good Automated Manufacturing Practice (GAMP).
• Strong knowledge (according to related area) of Computer System Validation, Kaye Validator, Serialization,
• Audits, Utilities, Facilities & Equipment Qualification, Process Validation, Product Transfer, Laboratory Equipment, Method Validation, Automation, Lean Manufacturing, Method Transfer, Packaging Line’s.
• Technical Writing skills and investigations processes.

Additional Information

All your information will be kept confidential according to EEO guidelines.