Facilities/Utilities Qualification Expert

EQVAL Group, Inc. is a company that provides services to the manufacturing industry (Medical Devices, Pharmaceuticals, Biotechnologies, others). We work with an extraordinary group of professionals (employees and contractors) to accomplish the requirements established by our customers, in order to perform and provide a highly effective service.

Education:

- Bachelor's in Sciences Degree in Natural Sciences or Engineering

Responsibilities:

• Plan, develop, and implement validation documentation, procedures, and training for the Engineering Team (Facilities & Utilities).
• Actively participate in the Validation Life Cycle of regulated projects, including reviewing validation documentation, defining application requirements, conducting risk assessments, and developing validation protocols.
• Generate Validation Plans, design documentation (URS, SDS) along with validation protocols (SAT/IQ/OQ/PQ) development and execution (thus requires excellent technical writing skills).
• Generate Facilities Qualification (Clean Rooms) documentation.
• Generate Critical Utilities qualification documentation (HVAC, Compressed Air, including Computer System Validation).
• Identify and implement methods for compliant computerized operations, ensuring adherence to procedures and documentation standards.
• Perform other project related duties as necessary.

Qualifications:

• Knowledge of FDA, OSHA, GMP and ISO requirements.
• Ability to lead complex projects and provide technical leadership.
• Thorough understanding of verification and validation processes
• Expertise in the Computer Systems Validation Life Cycle (GAMP 5 and FDA guidelines).
• Proficient in generating validation documentation, including Validation Plans and SOPs for Facilities Qualification (Clean Rooms) and Critical Utilities Qualification (HVAC, Compressed Air) Projects.
• Strong communication skills with a proven ability to work cross-functionally.
• Strategic thinker with a solid background in developing technical documentation and reports.
• Team-oriented and self-motivated.

Job Types: Full-time, Contract

Benefits:

• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Professional development assistance
• Referral program
• Vision insurance

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Work Location: In person