- 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.
#J-18808-Ljbffr
