Title: Senior C&Q Validations Engineer – Parallel Manufacturing Enablement Project

Location: East of Puerto Rico

Schedule: 100% Onsite

Position Summary

Our client is seeking an experienced Senior CQV Engineer to support a major Parallel Manufacturing Enablement Project within a regulated biotechnology manufacturing environment. The project focuses on enabling simultaneous manufacturing operations by eliminating shared-equipment dependencies and ensuring full segregation between production lines.

This role will lead and support Commissioning, Qualification, and Validation (CQV) activities associated with the procurement, installation, qualification, validation, and integration of new manufacturing equipment into existing production workflows.

The ideal candidate will possess extensive expertise in CQV lifecycle management, validation engineering, regulatory compliance, and cGMP manufacturing systems within the pharmaceutical or biotechnology industries.

Project Scope

The project includes qualification and integration support for new manufacturing equipment that replicates existing approved production assets, including:

• Single-use mixing systems
• Cell collection and hold tanks
• Centrifuge systems and associated controls

The selected consultant will support regulatory-compliant implementation of equipment into existing manufacturing operations while ensuring alignment with site procedures, validation standards, and inspection readiness expectations.

Key Responsibilities

Procurement Support

• Develop Commissioning, Qualification, and Validation Plans and Reports supporting the validation lifecycle
• Review and approve:
• User Requirements Specifications (URS)
• Risk Assessments
• Vendor technical documentation packages
• Support technical review of:
• Factory Acceptance Testing (FAT) documentation
• Acceptance criteria
• Generate, execute, and compile objective evidence supporting FAT activities
• Manage punch list items and support closure activities
• Generate and approve FAT reports and related documentation

Commissioning Activities

• Develop and execute commissioning plans aligned with ISPE Commissioning & Qualification principles
• Support or witness FAT activities, as applicable
• Support Site Acceptance Testing (SAT) activities
• Coordinate commissioning execution with cross-functional stakeholders and vendors

Qualification Activities

• Prepare, execute, and report qualification activities in alignment with site SOPs and regulatory requirements
• Support:
• Design Qualification (DQ)
• Installation Verification (IV)
• Operational Verification (OV)
• Verify:
• Equipment installation
• Utilities integration
• Materials of construction
• Instrumentation
• Alarms and interlocks
• Functional performance
• Ensure qualification protocols:
• Leverage vendor FAT testing when applicable
• Maintain traceability to URS and site requirements
• Follow Good Documentation Practices (GDP)

Validation Activities

• Generate and execute:
• Steam-In-Place (SIP) Performance Qualification protocols
• Cleaning Validation protocols
• Generate validation reports and summary documentation
• Support development and updates of:
• Validation Summary Reports (VSR)
• Qualification and validation documentation packages
• Update Site Master Validation documentation with qualification and validation deliverables

Production Workflow Integration

• Verify mechanical, electrical, automation, and utility integration into existing manufacturing systems
• Ensure alignment with:
• Existing operating procedures
• Batch execution models
• Manufacturing workflows
• Support compliant integration into active manufacturing operations

Additional Responsibilities

• Manage multiple complex CQV projects and project phases simultaneously
• Develop validation engineering practices and contribute to continuous improvement initiatives
• Organize and coordinate activities involving engineers, technicians, vendors, and cross-functional teams
• Resolve technical challenges and complex validation issues impacting project execution
• Develop standards, guidelines, and execution strategies for CQV activities
• Ensure all activities support audit and inspection readiness
• Maintain prompt and regular onsite attendance

Deliverables

The selected consultant will generate and support the following deliverables:

• Commissioning and Qualification Plans and Reports
• Validation Plans and Reports
• IV and OV protocols
• Qualification Summary Reports
• Risk Assessment support documentation
• Deviation, discrepancy, and change management support documentation
• Final CQV turnover package suitable for audit and inspection readiness

Qualifications

Candidates must meet one of the following education and experience requirements:

• Doctorate degree with 2 years of related experience
• OR
• Master’s degree with 6 years of related experience
• OR
• Bachelor’s degree with 8 years of related experience
• OR
• Associate degree with 10 years of related experience

Preferred fields include:

• Engineering
• Life Sciences
• Biotechnology
• Pharmaceutical Sciences
• Related technical disciplines

Required Experience & Skills

• Extensive experience in:
• Commissioning, Qualification, and Validation (CQV)
• Validation lifecycle management
• Pharmaceutical or biotechnology manufacturing environments
• Strong knowledge of:
• cGMP regulations
• ISPE C&Q principles
• Validation engineering
• Risk management
• Change control systems
• Experience supporting:
• FAT and SAT execution
• Equipment qualification
• Cleaning validation
• SIP validation
• Manufacturing system integration
• Strong technical writing and documentation skills
• Excellent organizational, analytical, and problem-solving abilities
• Proven project management and leadership capabilities
• Ability to manage multiple priorities within fast-paced regulated environments
• Strong verbal and written communication skills
• Experience supporting audit and inspection readiness initiatives

Scope Exclusions

The following activities are outside the scope of this role:

• Process development or process optimization activities
• Cycle development activities supported by equipment vendors
• Changes to:
• Batch records
• Control strategies
• Critical process parameters
• Product revalidation activities
• New product introduction activities

Work Environment

• 100% onsite role located on the east side of Puerto Rico
• Work performed within a regulated pharmaceutical manufacturing environment
• Collaboration with Quality, Manufacturing, Engineering, Validation, and Vendor teams required
• Project execution must support continued compliant manufacturing operations