Change Control Specialist

Who we are:

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 react faster, hit their targets, and maximize value within their project environment. In over 30 years of business, we’ve helped some of the world’s largest companies achieve their most complex goals.

We are looking for an experienced and passionate Engineering Change Manager to join our team in Zebulon, NC and support a diverse range of capital projects within pharmaceutical manufacturing and laboratory environments.

What you'll do:

As an MIGSO-PCUBED Engineering Change Manager, you will play a critical role in governing and controlling engineering design changes across the lifecycle of complex capital projects. You will ensure that all modifications to facilities, systems, and equipment are assessed, approved, documented, and implemented in compliance with regulatory standards and project objectives.

You will act as a central coordination point between engineering, quality, validation, construction, and operations teams, ensuring that engineering changes are delivered in a controlled, compliant, and efficient manner without negatively impacting cost, schedule, safety, or product quality.

As an MP Consultant, you will have the opportunity to:

• Work on large-scale pharmaceutical and life sciences capital projects
• Support facility builds, laboratory expansions, and manufacturing programs
• Collaborate with cross-functional teams across engineering, quality, and operations
• Drive best practices in change control, compliance, and project delivery
• Develop strong client relationships while contributing to MP’s growth

Your responsibilities will include:

Engineering Change Control & Governance

• Manage the engineering change control process across all project phases (design through commissioning and qualification)
• Establish and maintain change control procedures aligned with GMP and quality systems
• Lead or coordinate Change Control Review Boards (CCRB) to review and approve changes

Impact Assessment & Risk Management

• Evaluate engineering changes for impact on product quality, regulatory filings, validation status, cost, and schedule
• Lead structured risk assessments (e.g., FMEA, impact analysis) and mitigation planning
• Ensure risks are clearly documented, communicated, and managed

Cross-Functional Coordination

• Serve as the interface between engineering teams, contractors, quality, validation (CQV), and operations
• Ensure stakeholder alignment prior to approval and implementation of changes
• Resolve technical conflicts and drive consensus across teams

Documentation & Regulatory Compliance

• Ensure all engineering changes are properly documented within systems such as TrackWise, Veeva, MasterControl, or EDMS
• Maintain audit-ready documentation to support regulatory inspections (FDA, EMA, etc.)
• Ensure compliance with GMP, validation, and quality requirements

Project Integration & Controls

• Integrate engineering changes into project schedules, cost forecasts, procurement plans, and construction activities
• Prevent uncontrolled scope creep and manage design revisions effectively
• Support alignment between engineering changes and overall project delivery strategy

Commissioning, Qualification & Validation Alignment

• Ensure engineering changes are incorporated into commissioning plans and qualification protocols (IQ/OQ/PQ)
• Maintain traceability between design changes and validation documentation
• Support successful project handover and operational readiness

Stakeholder Communication & Reporting

• Provide reporting on change metrics, approval timelines, and risk levels
• Maintain dashboards and reporting tools for project and program leadership
• Communicate complex technical changes clearly to both technical and non-technical stakeholders

What we’re looking for:

• Bachelor’s degree in Engineering or related field (Master’s preferred)
• 8–15+ years of experience in engineering change management, project controls, or capital project delivery
• Strong experience in pharmaceutical, biotech, or life sciences environments

Technical Expertise:

• Deep understanding of GMP environments and regulatory requirements (FDA, EMA)
• Familiarity with GAMP5 and validation lifecycle (CQV processes)
• Knowledge of process equipment, cleanrooms, HVAC, utilities (WFI, clean steam), and automation systems
• Experience with engineering and quality systems (TrackWise, Veeva, MasterControl, Documentum, etc.)

Project & Risk Management:

• Strong understanding of capital project delivery across full lifecycle (design to handover)
• Ability to assess impact of engineering changes on cost, schedule, and scope
• Experience supporting large EPC/EPCM programs

Leadership & Communication:

• Proven ability to lead cross-functional teams and governance forums
• Strong stakeholder management and influencing skills
• Excellent written and verbal communication skills

Preferred Experience:

• Experience on large capital projects ($100M–$2B+)
• Background supporting manufacturing facilities, biologics plants, cleanrooms, or lab builds
• Ability to manage high volumes of engineering changes in complex environments

Benefits and Perks

At MP, our people are our pride and joy. We are committed to supporting your career and personal growth:

• Global networking opportunities across a diverse consulting community
• Exposure to multiple industries and high-impact projects
• Personalized career coaching and development plans
• Ongoing training, certifications, and learning opportunities
• Structured career progression framework
• Inclusive culture built on respect, team spirit, excellence, and 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. We are committed to equal employment opportunities in all aspects of employment.