Project Manager Pharma

groninger USA; Charlotte (NC); On-site; USD 90,000 - 120,000; Full time

Job summary

groninger USA seeks a Project Manager to lead pharmaceutical equipment and services projects from initiation through delivery, ensuring GMP/GDP/GAMP 5 compliance, strict scope control, and on-time, on-budget execution.

This execution-focused role requires strong organizational discipline and coordination across engineering, service, logistics, and quality teams, while serving as a primary customer-facing representative to ensure successful project outcomes and sustained client relationships.

Qualifications

• Bachelor’s degree or equivalent experience.
• 2+ years of project management experience in pharma/biotech/engineering.
• GMP, GDP and GAMP 5 knowledge.
• Experience coordinating validation activities (FAT/SAT, IQ/OQ/PQ).
• Strong documentation discipline in regulated environments.
• Proficient with MS Office; Allex.ai, PSI Penta, Remberg preferred.

Responsibilities

• Lead pharmaceutical customer projects from kickoff to completion.
• Maintain scope, deadlines, and deliverables, controlling scope creep.
• Monitor budgets, margins, cost tracking and forecasting.
• Maintain project timelines using Allex.ai and coordinate with teams.
• Drive accountability among internal contributors to stay on track.
• Coordinate validation-related activities and documentation readiness.

Skills

GMP/GDP/GAMP 5 knowledge

Strong communication skills

Problem-solving

Attention to detail

Multitasking

Relationship building

Education

Bachelor’s degree or equivalent experience

Tools

Allex.ai

PSI Penta

Remberg

Job description

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
• Check out a day in the life here: https://youtu.be/HQGzIGyqRbs?si=uL9wSqayQ1-TMiqs
• Click here to learn more about our culture and benefits:

https://youtu.be/V3c8XcT4oXI?si=bI3eDQCA07FvVMi6

• For the latest happenings and company information, check us out here: https://www.linkedin.com/company/groningerusa

Position Summary

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.