Senior Validation & Quality Engineer – CSV Specialist

Validation & Engineering Group; Guaynabo (PR); On-site; Full time

Job summary

A leading services supplier in Guaynabo seeks talented individuals for validation roles in the Pharmaceutical and Biotechnology sectors. Candidates should possess a Bachelor's degree in Science and Engineering, and a minimum of 3 years of relevant experience. Proficiency in both English and Spanish is required, along with strong knowledge of cGxP regulations and technical writing skills. The role involves performing Computer System Validation, and Quality Engineering tasks to ensure compliance with regulatory standards.

Qualifications

• Bachelor's degree required.
• 3+ years experience in pharmaceutical or biotechnology industries.
• Must be bilingual with strong writing skills.
• Proficient in MS Windows and Office applications.
• Knowledge of FDA guidelines and cGMP regulations.

Responsibilities

• Perform Computer System Validation and Cleaning Validation.
• Manage projects related to quality and compliance.
• Engage in audits and ensure process validation.

Skills

Bilingual (English / Spanish)

Technical Writing

Knowledge of cGxP regulations

Computer System Validation

Education

Bachelor's Degree in Science and Engineering

Tools

MS Windows

Microsoft Office

Kaye Validator

Job description

Validation & Engineering Group (VEG) is a leading services supplier provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

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
• 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.

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