Project Manager Pharma

• Location 14045 South Lakes Drive,Charlotte, NC, 28273,United States
• Employee Type FT Exempt
• Required Degree 4 Year Degree
• Travel 35%
• Manage Others No

What's awesome about working for groninger?

• 20 PTO days per calendar year and 11 paid holidays
• Competitive pay with opportunities for overtime
• Fresh fruit delivered every Monday!
• Gym reimbursement
• Extremely competitive benefits with significant employer contribution
• Snacks and engagement events
• Strong safety culture and supportive leadership
• Opportunities for continuous learning, skill development and cross-training across a variety of roles and processes
• A growing company that invests in continuous improvement, training and internal growth
• Temperature controlled manufacturing plant
• Click here to learn more about our culture and benefits:

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

• Lead and manage pharmaceutical customer projects from kick-off to completion, ensuring scope, deadlines, and deliverables are met.
• Maintain strict control over scope, preventing scope creep through structured communication and change control.
• Monitor and manage project budgets, including cost tracking, margin monitoring, and forecasting.
• Maintain project timelines using Allex.ai and ensure adherence through proactive planning and stakeholder coordination.
• Drive accountability among internal contributors to keep projects on track.

Regulatory & Compliance Coordination

• Ensure project execution complies with GMP, GDP, and GAMP 5 requirements.
• Coordinate activities related to FAT/SAT, qualification preparation (IQ/OQ/PQ awareness), and documentation readiness.
• Support deviation handling, CAPA direction from Quality, and proper documentation revision control.
• Ensure structured, traceable project communication aligned with pharmaceutical regulatory expectations.

Technical & Documentation Support

• 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.
• Ensure all project documentation is complete, accurate, and delivered to the customer on time.
• Prepare Field Service Technicians and internal teams by ensuring they have complete, correct, and up-to-date information.
• Oversee readiness of materials and documents required for FAT, shipment, installation, start-up and SAT.

Stakeholder Communication & Coordination

• Lead project kick-off meetings and align internal and external stakeholders on scope, responsibilities, deliverables, and expectations.
• Communicate project status, risks, and mitigation plans to customers, internal teams, and management with clarity and structure.
• Maintain strong professional relationships with customers, coworkers, and vendors.
• Manage meeting notes, action items, decisions, and follow-ups with documentation discipline required in pharmaceutical environments.

Operational Coordination

• Monitor shipment schedules and coordinate with Logistics to ensure on-time delivery of equipment and materials.
• Ensure ticketing, communication, and documentation processes are followed in Remberg and PSI Penta.
• Support cost optimization efforts without compromising compliance or quality.
• Participate in continuous improvement initiatives through lessons learned tasks after completion of a project.

Qualifications

Required

• Bachelor’s degree or equivalent experience.
• 2+ years of experience in project management, preferably within pharma, biotech, engineering, or automation environments.
• GMP, GDP and GAMP 5 knowledge.
• Experience working with regulated pharmaceutical customers.
• Experience coordinating validation-related activities (FAT/SAT, IQ/OQ/PQ awareness).
• Strong understanding of documentation discipline required in regulated environments.
• Proficiency in project management software; experience with Allex.ai preferred.
• Experience with ERP systems (PSI Penta preferred) and ticketing systems (Remberg).
• Strong problem-solving skills, communication skills, and meticulous attention to detail.
• Ability to manage multiple high-priority tasks simultaneously.
• Proficient with Microsoft Office Suite.
• Strong relationship-building and customer-facing skills.
• Ability to adapt quickly in a dynamic environment with changing priorities.

Preferred

• Experience with aseptic processing, pharmaceutical machinery, or fill-finish equipment.
• Familiarity with 21 CFR Part 11 concepts (audit trails, electronic records).
• Understanding of cleanroom classifications (ISO 5–8).
• Experience reviewing URS, FDS, HDS, SDS, or related specification documents.
• Six Sigma Yellow or Green Belt.
• Manufacturing background.
• Financial acumen and basic understanding of cost structures.

Additional Information

• Travel required up to 35% based on project needs.
• This role is designed as an operational project management role with a strong focus on execution.
• The Project Manager role can serve as a development pathway toward Senior Project Manager for individuals demonstrating high performance, regulatory competence, and leadership potential.