Technical Project Manager

SimoTech • Raleigh, NC

19h • Hybrid

About The Position

SimoTech fosters a strong collaborative teamwork culture based on respect, trust, and excellence, playing a critical partnering role to clients’ life-changing supply of products to patients. SimoTech offers excellent salary, benefits, career progression, and educational support. This new opportunity is for a Technical Project Manager with a minimum of 5 years’ experience to join the team supporting a leading Biopharmaceutical based in North Carolina. The role involves leading the delivery and integration of critical manufacturing applications and infrastructure in full compliance with industry regulations. The ideal candidate will have experience in delivery projects within a regulated pharmaceutical environment and strong knowledge of manufacturing IT/OT systems, including MES and historian platforms.

Requirements

• Knowledge of GAMP software development lifecycle, ANSI/ISA -S88 and S95 industry standards, 21 CFR Part 11 and Annex 11
• Proven experience implementing or managing platforms like Werum PAS -X or Siemens Opcenter
• Specific proficiency with AVEVA PI (PI System) for real -time data capture and KPI tracking
• Understanding of the interface between Information Technology (IT) and Operational Technology (OT), including DCS (Distributed Control Systems), PLC (Programmable Logic Controllers), and ERP (SAP)
• Oversight of backup and recovery applications to ensure high availability and disaster recovery for critical manufacturing lines
• Working knowledge of network architecture technologies including TCP/IP, Routing, Switching (Cisco/Stratix/DeltaV Smart), VLAN’s, Active Directory, Domain Integration and Firewalls
• Independent, self -motivated, organized, and able to multi -task in a manufacturing environment
• Team player, prepared to work in and embrace a team -based culture that relies on collaboration for effective decision-making
• Solid technical writing, and communication/presentation skills
• Proficient in managing relationships with stakeholders; coordinating and collaborating with teams from different departments to achieve common goals
• Bachelor’s degree in Engineering, Computer Science, or Life Sciences is required
• 5+ years of project management experience specifically within a regulated pharmaceutical or biotech manufacturing environment
• Strong stakeholder management skills to coordinate between site engineers, quality assurance, and external vendors

Nice To Haves

• Experience with Thin Manager and Factory Talk Asset Centre a plus
• A Master's or MBA is preferred
• PMP (Project Management Professional) or Lean Six Sigma Green/Black Belt certification is highly valued

Responsibilities

• Leading the delivery and integration of critical manufacturing applications and infrastructure in full compliance with industry regulations

Benefits

• Excellent salary
• Benefits
• Career progression
• Educational support
• Opportunity to work with large corporate clients on exciting capital projects
• Role provides a high degree of autonomy to allow the successful candidate to reach their full potential
• Develop new skills and enhance technical ability by working with innovative technologies
• Hybrid working model

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Number of Employees: 11-50 employees