Senior CQV Engineer Rocky Mount, North Carolina

Responsibilities:

1. CQV Activities:

Leads and executes Commissioning, Qualification, and Validation (CQV) activities for De-Ionized Water Pre-treatment Systems, and related distribution networks.Develops and implements CQV protocols (IQ, OQ, PQ) in compliance with regulatory requirements and industry standards.Conducts risk assessments and develops mitigation strategies for CQV processes.Performs equipment and system troubleshooting to resolve issues arising during CQV phases.Ensures proper documentation and traceability of CQV activities.2. CSV Activities:

Leads and executes Computer System Validation (CSV) activities for related control systems and software.Develops and implements CSV protocols in compliance with regulatory requirements and industry standards.Performs validation of SCADA, PLCs, and other control systems to ensure proper integration and functionality.Ensures proper documentation and traceability of CSV activities.3. Project Management:

Leads and manages CQV and CSV projects from initiation to completion, ensuring adherence to timelines and budgets.Coordinates with internal and external stakeholders to ensure successful project execution.Prepares and presents project status reports to management and clients.Manages project documentation, including specifications, protocols, and reports.4. Compliance and Quality Assurance:

Ensures all CQV and CSV activities comply with GMP, FDA, and other regulatory requirements.Conducts audits and inspections to verify compliance and readiness for regulatory reviews.Implements quality assurance processes and continuous improvement initiatives.Trains and mentors junior engineers and technicians on CQV and CSV best practices.5. Documentation and Validation Activities:

Develops, issues, reviews, and approves User Requirement Specifications.Conducts Equipment Classification Assessments managing associated documentation.Prepares, reviews, and approves Project Validation Plans.Performs and documents Risk Assessments.Develops, reviews, and approves Design Qualifications.Follows up on vendor testing activities during Site Acceptance Tests (SAT).Issues, reviews, approves, and tests Commissioning documents for non-GMP utilities.Prepares, reviews, and approves Commissioning of non-GMP Utilities Reports.Develops, reviews, approves, and tests Installation and Performance Qualification (IQ/PQ) for GMP utilities.Prepares, reviews, and approves Installation and Performance Qualification Reports for GMP utilities.Issues, reviews, approves, and tests Installation Qualification (IQ) Protocols.Prepares, reviews, and approves Installation Qualification Reports.Develops, reviews, approves, and tests Operational Qualification (OQ) Protocols.Prepares, reviews, and approves Operational Qualification Reports.Develops, reviews, approves, and tests Performance Qualification (PQ) Protocols (sampling and results provided by Pfizer).Prepares, reviews, and approves Performance Qualification Reports.Issues Traceability Matrices.6. Construction Turnover Package Verification:

Conducts in-depth verification of construction turnover packages.Reviews and verifies material of construction certificates.Assesses elastomers and O-rings certificates for compliance.Validates welding documentation, ensuring adherence to standards.Performs slope checks to ensure proper drainage and flow.Verifies piping labels, component, and instrumentation labeling.Ensures insulation requirements are met and documented.7. Design Engineering for De-Ionized Water Systems:

Designs and develops De-Ionized Water Pre-treatment Systems and related distribution infrastructure.Creates and reviews detailed engineering drawings, P&IDs, and specifications.Ensures designs comply with industry standards, regulatory requirements, and best practices.Collaborates with process engineers to optimize system design and performance.Performs system sizing calculations and components selection.Develops and reviews technical documents, including design specifications, equipment datasheets, and functional descriptions.Provides engineering support during installation, commissioning, and validation phases.Education:Bachelor’s or Master’s degree in Engineering (Chemical, Mechanical, Electrical, or related field).Preferred Qualifications:Minimum of 8 years of experience in CQV with a focus on De-ionized Water Pretreatment systems, Pharmaceutical Water systems, Pure Steam Generators, and related distribution networks.Strong knowledge of GMP, FDA, and other relevant regulatory requirements.Excellent project management skills with the ability to lead and manage multiple projects simultaneously.Strong problem-solving and troubleshooting skills.Excellent communication and interpersonal skills.Proficiency in design engineering for Pure Steam Generator and De-Ionized Water systems, including creating P&IDs and engineering drawings.Experience with system sizing calculations and component selection.Skills:Experience with pharmaceutical or biotech manufacturing environments.Certification in Project Management (PMP) or CQV.Experience with risk-based integrated CQV approaches.Work Methodology:100% Work On-siteProfessional Service Contract2 years - First ContractProject Starting in March 2025Able to work in a manufacturing environment, including cleanroom settings.

#J-18808-Ljbffr