Engineering Change Management Specialist (Upper Merion)

Who are we?

At MIGSO-PCUBED, our mission is to support delivery of our clients’ most important projects and programs. We take pride in delivering world-class project, program and portfolio management expertise and services to clients in every industry. We are specialists in helping businesses to react faster, hit their targets and maximize value within their project environment. In the 30+ years that we’ve been in business, we’ve helped some of the world’s largest companies achieve their most complex goals.

We are looking for an experienced and passionate Change expert to join our New York Hub to support a diverse range of projects and industry leading clients.

Engineering Change Manager

Role Overview (Pharmaceutical Manufacturing & Lab Build Programs)

An Engineering Change Manager is responsible for governing and controlling all engineering design changes across the lifecycle of pharmaceutical manufacturing facilities, laboratories, and associated process systems. The role ensures that modifications to facility design, process equipment, utilities, and automation systems are properly evaluated, approved, documented, and implemented while maintaining compliance with GMP regulations, validation requirements, and project delivery objectives .

Within large capital programs—such as drug manufacturing plant builds, biologics facilities, or laboratory expansions —the Engineering Change Manager acts as the central coordination point between engineering, project management, quality, validation, regulatory, construction, and operations teams .

The objective is to ensure that engineering changes are implemented in a controlled, compliant, and traceable manner without negatively impacting schedule, cost, safety, product quality, or regulatory approval timelines .

Core Responsibilities

1. Engineering Change Control Governance

• Manage the engineering change control process across design, procurement, construction, commissioning, and qualification phases.
• Establish and maintain change control procedures aligned with GMP and quality systems .
• Chair or coordinate Change Control Review Boards (CCRB) for engineering changes.

2. Impact Assessment and Risk Management

• Evaluate engineering changes for impacts on:
• Product quality
• Regulatory filings
• Validation and qualification status
• Project cost and schedule
• Safety and operational performance
• Lead technical risk assessments and mitigation planning.

3. Cross-Functional Coordination

• Serve as the interface between:
• Engineering and design firms
• Construction contractors
• Quality and regulatory teams
• Validation and CQV teams
• Manufacturing and operations
• Ensure alignment across all stakeholders prior to approval and implementation of changes.

4. Documentation and Regulatory Compliance

• Ensure engineering changes are fully documented within controlled systems such as:
• Change Control systems (TrackWise, Veeva, MasterControl, etc.)
• Document management systems
• Commissioning & qualification records
• Maintain audit-ready documentation to support FDA, EMA, and regulatory inspections .

5. Project Integration

• Integrate engineering changes into:
• Project schedules
• Cost forecasts
• Procurement updates
• Construction work packages
• Prevent uncontrolled scope creep and coordinate design revisions.

6. Commissioning, Qualification, and Validation Alignment

• Ensure engineering changes are properly incorporated into:
• Commissioning plans
• Qualification protocols (IQ/OQ/PQ)
• Process validation documentation
• Maintain traceability between design changes and validation impacts .

7. Stakeholder Communication and Reporting

• Provide leadership reporting on:
• Change volume
• Approval timelines
• Risk level of changes
• Schedule or cost impacts
• Maintain change dashboards for program leadership.

Key Skills and Expertise

Pharmaceutical / Life Sciences Expertise

• Deep understanding of GMP environments
• Knowledge of FDA, EMA, and global regulatory expectations
• Familiarity with GAMP5 and validation lifecycle
• Experience supporting drug substance, drug product, or biologics facilities

Capital Project Delivery Experience

Experience supporting large capital programs such as:

• Pharmaceutical manufacturing facilities
• Biologics production plants
• Fill-finish manufacturing lines
• Cleanroom facilities
• Research laboratories
• Process utility systems
• Strong understanding of engineering design through commissioning lifecycle .

Engineering & Technical Knowledge

Working knowledge of:

• Process equipment and manufacturing systems
• Cleanroom design and classification
• HVAC and environmental control systems
• Process utilities (WFI, clean steam, compressed gases)
• Automation and control systems
• Equipment installation and integration
• Ability to evaluate technical design changes and their operational implications .

Change Control & Quality Systems

Expertise with:

• Engineering change management processes
• Quality management systems (QMS)
• Deviation and CAPA processes
• Configuration management
• Documentation control

Experience with platforms such as:

• TrackWise
• Veeva Quality
• MasterControl
• Documentum
• EDMS systems

Risk Management & Analytical Skills

Ability to lead structured assessments including:

• Impact analysis
• Failure mode analysis (FMEA)
• Risk ranking and prioritization
• Technical change justification

Project Controls & Program Management

Understanding of how engineering changes affect:

• Cost management
• Schedule control
• Procurement timelines
• Construction sequencing
• Project scope management

Experience coordinating changes within large EPC or EPCM programs .

Leadership & Stakeholder Management

Senior-level profile requires:

• Leading cross-functional review boards
• Influencing engineering and quality leadership
• Resolving technical conflicts between stakeholders
• Communicating clearly with executive project sponsors

Digital Tools & Systems

Familiarity with:

• Engineering document management systems
• Capital project management platforms
• Change management software
• Data dashboards and reporting tools

Indicators of a Senior Engineering Change Manager

A senior professional in this role typically demonstrates:

• Experience on large pharmaceutical capital projects ($100M–$2B+)
• Leadership of complex change control programs
• Strong credibility with quality, validation, and regulatory teams
• Ability to manage hundreds of engineering changes during facility build phases
• Proven ability to protect project schedule and regulatory compliance simultaneously

Some of Our Key Benefits

At MP, our people are our pride and joy. That’s why we care about what we can do for YOU and your career. Here are a few reasons why you’ll love working with us:

• Global Networking: Connect with a diverse community of project managers from around the world.
• Multi-Industry Exposure: Expand your horizons across various industries and domains, becoming a versatile expert.

• Personalised Career Coaching: Receive one-on-one guidance to help you navigate and advance your career path.

• Continuous Learning: Immerse yourself in a culture of learning with certification trainings, internal seminars, training courses, and more.

• Career Progression: Grow with us through our structured career development framework.

• Inclusive Culture: Be part of a culture that values diversity, respect, team spirit, excellence, and unwavering commitment.

Equal Opportunity Statement

MIGSO-PCUBED recognizes the civil right of every person to obtain and maintain employment without discrimination. We have a longstanding policy that no individual may be refused a job, discharged, or discriminated against in any way due to any protected characteristics established by local, state and Federal law. In all respects, MIGSO-PCUBED is committed to a policy of full and fair equal employment under the law and applies this in all employment decisions, including recruitment, hiring, compensation, ]]> <