Project Manager - Plant Transfer

L&T Technology Services; Arvada (CO); On-site; USD 68,000 - 130,000; Full time

Benefits offered by this job

Paid Leave

Health Insurance

Group Life Insurance

Disability

401(K)

Job summary

L&T Technology Services is seeking a Plant Transfer Project Manager to oversee strategy, planning, execution, risk management, and regulatory compliance for successful product transfers and uninterrupted customer supply. You will serve as the single point of contact across Manufacturing, Quality, Supply Chain, Engineering, Regulatory, Procurement, Finance, IT, and contract manufacturers.

This role requires 12+ years in program management and 5+ years in medical devices, with strong leadership,

Qualifications

• 12+ years of experience in Program Management.
• 5+ years experience in the medical device industry, preferably with sterile disposable medical devices.
• Quality Systems
• Cross-functional leadership
• PMP or equivalent preferred
• Strong experience with Microsoft Project or other Project Management software.

Responsibilities

• Oversee plant transfer strategy, planning, execution, risk management, regulatory compliance.
• Maintain a 'single source of truth' for project plans, milestones, and budgets.
• Develop and manage integrated project plans and critical path activities.
• Coordinate governance structures, steering committees, and cross-functional workstreams.
• Drive decision-making and issue resolution across stakeholders.
• Track program status, risks, and KPIs, and communicate with leadership.

Skills

Cross-functional leadership

Problem solving

Financial analysis

Root cause investigation

Influencing without authority

Education

PMP Certification

Tools

Microsoft Project

PM software

Job description

The Plant Transfer Project Manager will oversee strategy, planning, execution, risk management, regulatory compliance, qualification, product transfer, supply chain transition, knowledge transfer, and business continuity to ensure successful commercialization and uninterrupted customer supply. The individual will act as the single point of contact across Manufacturing, Quality, Supply Chain, Engineering, Regulatory Affairs, Procurement, Finance, IT, and Contract Manufacturing partners.

• Maintain a 'single source of truth' for overall project plans – including schedules, budgets, milestones, tasks, and deliverables – ensuring alignment across all teams.
• Develop and manage integrated project plans, milestones, and critical path activities.
• Execute the overall plant transfer strategy and roadmap inline with the CM plan.
• Support Project Head with establishing governance structure, steering committees, and cross-functional workstreams.
• Drive decision-making and issue resolution across multiple stakeholders.
• Provide guidance and direction to project team members as necessary, assisting in clearing barriers to progress.
• Resolve resource issues and facilitate reallocation of activities and efforts to ensure schedules are achieved.
• Support Project Head in providing regular updates on program status, challenges, and risks to functional leadership and senior management.
• Support Project Head in facilitating regular cross-functional core team meetings to align on program goals, track progress, and address any issues or risks promptly.
• Support Project Head in preparing materials for the STC, PRC and other cross-functional meeting by co-ordinating with core team members.
• Collect, maintain, and monitor program-level KPIs dashboard to identify potential issues early and drive continuous improvement in delivery.
• Track project expenditures and savings.
• Monitor transfer-related capital investments.

Manufacturing Transfer Management

• Coordinate transfer of manufacturing processes and technical documentation.
• Ensure continuity of supply during transition and stabilization phase.

Product & Process Transfer

• Ensure complete transfer of:
  • Bills of Materials (BOM)
  • Manufacturing Instructions
  • Process Specifications
  • Test Methods
  • Validation Protocols
  • Equipment Parameters
  • Product History Records
• Coordinate with CM- pilot builds, engineering builds, and production qualification runs.

Quality & Regulatory Compliance

• Ensure compliance with:
  • FDA 21 CFR Part 820
  • EU MDR
  • ISO 13485
  • GMP requirements
  • Customer quality requirements
• Facilitate Quality Management System (QMS) transfer activities.
• Manage validation strategy in discussion with internal team including:
  • IQ
  • OQ
  • PQ
  • Process Validation
  • Cleaning Validation
  • Sterilization Validation (where applicable)

Supply Chain & Procurement

• Ensure inventory build strategy supports uninterrupted supply to customers.
• Coordinate transfer of logistics, warehousing, and distribution activities.

Knowledge Transfer

• Coordinate Subject Matter Expert (SME) engagement between OEM and CMO.
• Ensure training and certification of receiving-site personnel.
• Establish documentation and lessons-learned repository.
• Identify program risks and develop mitigation strategies.
• Conduct risk assessments including:
  • Business Continuity Risks
  • Supply Risks
  • Regulatory Risks
  • Operational Risks
  • Capacity Risks
• Develop contingency and recovery plans.

Stakeholder Management

• Manage relationships with:
  • Contract Manufacturing Organization
  • Internal functions
• Facilitate governance meetings and executive communication.
• Facilitate negotiation of priorities, timelines, and resource requirements.
• Track project expenditures and savings.
• Monitor transfer-related capital investments.

Required Qualifications:

• 12+ years of experience in Program Management.
• 5+ years experience in the medical device industry, preferably with sterile disposable medical devices.
• Quality Systems
• Cross-functional leadership
• PMP or equivalent preferred
• Strong experience with Microsoft Project or other Project Management software.
• Influencing without authority
• Problem solving
• Financial analysis
• Root cause investigation

Project Delivery

• Transfer completed on schedule
• Achievement of milestone dates

Paid Leave, Health Insurance, Group life insurance, Disability, 401(K)

The expected salary range for this position is between $67,500 to $1,30,000 annually. The actual salary may vary based upon several factors including, but not limited to, relevant skills/experience, time in role, base salary of internal peers, prior performance, business line, and geographic/office location.