November 1, 2024

Engineering, Quality and VALidation (EQVAL) Consulting Group

Añasco

FULL TIME & CONTRACT

Facilities/Utilities Qualification SME

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 documentation, procedures, and training for the engineering team.
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, User Requirement Specifications (URS), Functional Requirement Specifications (FRS), System Design Specifications (SDS), and traceability matrices, along with executing validation protocols (FAT/SAT/IQ/OQ/PQ) and completion reports.
Provide statistical analysis to support validation reports and develop sampling plans for in-process and final testing.
Review and approve validations and completion reports for new and existing computer and automation systems.
Troubleshoot computer and automation systems during validation runs and recommend process improvements.
Identify and implement methods for compliant computerized operations, ensuring adherence to procedures and documentation standards.
Analyze test results against predetermined criteria, evaluate non-conformance incidents, and complete CAPA investigations.
Manage installation of equipment and software modifications for automated systems, including vendor selection, budgeting, and coordination.
Lead process improvement projects to enhance the validation of computerized systems and oversee validation contractor resources.
Generate metrics to monitor Validation System performance and prepare reports for Quality Management Reviews.
Foster cross-functional relationships with Manufacturing, Engineering, Regulatory, and Quality Assurance teams.
Participate in external audits (e.g., FDA, BSI) and contribute to technical documentation for regulatory submissions.
Perform other related duties as necessary.

Qualifications:

Knowledge of FDA, OSHA, EPA, GMP, and ISO requirements.
Familiarity with Organizational Excellence and Lean/Six Sigma principles.
Strong project management skills and experience in cost control and training program development.
Ability to lead complex projects and provide technical leadership.
Thorough understanding of verification and validation processes, including software defect detection and testing methodologies.
Expertise in the Computer Systems Validation Life Cycle (GAMP 5 and FDA guidelines).
Proficient in generating validation documentation, including Validation Plans and SOPs.
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.