Position Summary
Reports to: VP of Technology
Location: Charlotte, NC
Travel: Up to 35%
The Project Manager will independently lead pharmaceutical equipment and services projects from initiation through delivery, ensuring compliance with GMP/GDP standards, strict control of project scope, timelines, and budgets, and alignment with customer expectations. This role is highly execution-focused, requiring strong organizational discipline, technical understanding of regulated pharmaceutical environments, and consistent coordination across engineering, service, logistics, and quality teams. The Project Manager serves as a key customer-facing representative and plays a critical role in ensuring successful project outcomes.
Key Responsibilities
Project Leadership & Execution
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Lead and manage pharmaceutical customer projects from kick-off to completion, ensuring scope, deadlines, and deliverables are met.
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Maintain strict control over scope, preventing scope creep through structured communication and change control.
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Monitor and manage project budgets, including cost tracking, margin monitoring, and forecasting.
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Maintain project timelines using Allex.ai and ensure adherence through proactive planning and stakeholder coordination.
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Drive accountability among internal contributors to keep projects on track.
Regulatory & Compliance Coordination
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Ensure project execution complies with GMP, GDP, and GAMP 5 requirements.
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Coordinate activities related to FAT/SAT, qualification preparation (IQ/OQ/PQ awareness), and documentation readiness.
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Support deviation handling, CAPA direction from Quality, and proper documentation revision control.
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Ensure structured, traceable project communication aligned with pharmaceutical regulatory expectations.
Technical & Documentation Support
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Maintain comprehensive understanding of the full project lifecycle, including URS/SOW interpretation, engineering documentation (FDS/HDS/SDS), risk assessments (such as FMEA), and equipment lifecycle steps.
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Ensure all project documentation is complete, accurate, and delivered to the customer on time.
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Prepare Field Service Technicians and internal teams by ensuring they have complete, correct, and up-to-date information.
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Oversee readiness of materials and documents required for FAT, shipment, installation, start-up and SAT.
Stakeholder Communication & Coordination
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Lead project kick-off meetings and align internal and external stakeholders on scope, responsibilities, deliverables, and expectations.
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Communicate project status, risks, and mitigation plans to customers, internal teams, and management with clarity and structure.
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Maintain strong professional relationships with customers, coworkers, and vendors.
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Manage meeting notes, action items, decisions, and follow-ups with documentation discipline required in pharmaceutical environments.
Operational Coordination
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Monitor shipment schedules and coordinate with Logistics to ensure on-time delivery of equipment and materials.
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Ensure ticketing, communication, and documentation processes are followed in Remberg and PSI Penta.
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Support cost optimization efforts without compromising compliance or quality.
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Participate in continuous improvement initiatives through lessons learned tasks after completion of a project.
Qualifications
Required
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Bachelor’s degree or equivalent experience.
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2+ years of experience in project management, preferably within pharma, biotech, engineering, or automation environments.
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GMP, GDP and GAMP 5 knowledge.
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Experience working with regulated pharmaceutical customers.
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Experience coordinating validation-related activities (FAT/SAT, IQ/OQ/PQ awareness).
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Strong understanding of documentation discipline required in regulated environments.
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Proficiency in project management software; experience with Allex.ai preferred.
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Experience with ERP systems (PSI Penta preferred) and ticketing systems (Remberg).
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Strong problem-solving skills, communication skills, and meticulous attention to detail.
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Ability to manage multiple high-priority tasks simultaneously.
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Proficient with Microsoft Office Suite.
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Strong relationship-building and customer-facing skills.
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Ability to adapt quickly in a dynamic environment with changing priorities.
Preferred
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Experience with aseptic processing, pharmaceutical machinery, or fill-finish equipment.
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Familiarity with 21 CFR Part 11 concepts (audit trails, electronic records).
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Understanding of cleanroom classifications (ISO 5–8).
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Experience reviewing URS, FDS, HDS, SDS, or related specification documents.
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Six Sigma Yellow or Green Belt.
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Manufacturing background.
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Financial acumen and basic understanding of cost structures.
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German language skills.
Additional Information
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Travel required up to 35% based on project needs.
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This role is designed as an operational project management role with a strong focus on execution.
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The Project Manager role can serve as a development pathway toward Senior Project Manager for individuals demonstrating high performance, regulatory competence, and leadership potential.
