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Technical Project Manager Controls & Data Systems

Group Nine LLC
2 hours ago
Contract
California
United States
Technical Project Manager Controls & Data Systems

Location: Northridge, CA. Must be onsite. Locals Only 6+ month contract only. Department: Manufacturing Science and Technology (MSAT) Reports To: Senior Manufacturing Operations Manager MSAT

We are a Drug Delivery leader in combination product development and manufacturing, specializing in complex drug delivery platforms including transdermal patches and inhalation systems. As a contract development and manufacturing organization (CDMO), we partner with top pharmaceutical companies to bring innovative therapies to market.

Role Overview

We are seeking a Technical Project Manager with a strong engineering background and proven project management expertise to lead initiatives involving control systems, data acquisition, and pharmaceutical manufacturing processes. This role is critical in supporting late-stage development, technical transfer, and commercialization, with a strong focus on project execution, compliance, and customer engagement. The ideal candidate will combine technical depth with project leadership skills, thrive in a fast-paced CDMO environment, and ensure successful delivery of complex pharmaceutical programs.

Key Responsibilities

Project Management & Leadership Lead technical projects from initiation through completion, ensuring scope, schedule, and budget adherence. Develop and maintain project plans, risk assessments, and resource allocation strategies. Coordinate cross-functional teams including R&D, Quality, Regulatory, and Operations. Ensure compliance with GMP, FDA, and regulatory requirements throughout project execution. Technical Expertise Oversee design, implementation, and optimization of control systems and data acquisition platforms supporting pharmaceutical manufacturing. Support technical transfer activities for transdermal patch and metered dose inhaler (MDI) programs. Guide system integration, testing, and validation activities to meet industry standards. Apply QbD principles and statistical tools (DoE, FMEA, Gage R&R) to drive data-driven decisions. Customer Engagement Act as primary project contact for clients, supporting project kick-offs, technical reviews, and troubleshooting. Communicate complex technical concepts clearly and professionally to external stakeholders. Support client audits and regulatory inspections as a subject matter expert. Continuous Improvement Identify and implement improvements in process robustness, product quality, and operational efficiency. Contribute to Lean initiatives and best practice sharing across programs.

Qualifications

Bachelor's or Master's degree in Engineering (Chemical, Electrical, Mechanical, Biomedical, or related field). Project Management Professional (PMP) certification or equivalent required. 7+ years of experience in pharmaceutical manufacturing with exposure to transdermal patch and/or MDI programs. Strong technical background in control systems, automation, and data acquisition technologies. Proven success in managing technical projects within a CDMO or regulated manufacturing environment. Excellent communication, leadership, and stakeholder management skills. Experience with cGMP environments and combination product requirements.

Preferred Skills

Familiarity with coating, laminating, die-cutting (for patches), and filling/crimping (for MDIs). Experience preparing CMC documentation for regulatory submissions (NDA/ANDA). Lean Six Sigma or continuous improvement certification is a plus.