Pharmaceutical Software Developer Jobs in Raleigh, NC

SP Industries, Inc. is expanding our team in and has an opening for a Senior Systems Engineer. We’re looking for a Senior Systems Engineer who wants true technical ownership – someone ready to step beyond a single discipline and take responsibility for how complex systems come together, perform, and succeed in the field.

In this role, you’ll be the technical glue across mechanical design, controls, automation, process engineering, quality, and manufacturing. You’ll work at the system level to ensure our pharmaceutical equipment meets customer needs, regulatory expectations, and long‑term performance goals—from early concept through qualification and deployment.

This position is a strong fit for an experienced engineer who:

• Enjoys seeing the whole system, not just their piece of it
• Wants more authority, accountability, and visibility
• Is looking for a clear path into senior technical leadership or principal‑level roles

What You'll Own

You’ll be embedded on‑site with a pharmaceutical customer, taking hands‑on ownership of two aseptic filling systems. Your mission is to stabilize, improve, and guide these systems through successful IQ/OQ, working closely with internal teams and the customer.

This is a visible role where your technical judgment matters. You’ll have the opportunity to:

• Build trust with a key customer through sound engineering decisions
• Drive issues to closure with cross‑functional teams
• Directly influence system architecture, integration strategy, and execution

Key Responsibilities

System Architecture and Requirements

• Translate customer, GMP, and regulatory requirements into clear, verifiable system-level requirements.
• Define and maintain system architectures spanning mechanical, controls, automation, utilities, vacuum, refrigeration, and process interfaces.
• Manage requirements traceability through design, verification, validation, and change management.

Technical Integration and Risk Management

• Lead cross-disciplinary integration across mechanical, electrical, controls, software, and process engineering teams.
• Facilitate system-level design reviews, trade studies, and risk analyses, including FMEAs.
• Identify and mitigate integration risks impacting performance, reliability, safety, and compliance.

Design Oversight and Execution

• Provide technical oversight for major subsystems such as chambers, shelves, condensers, fill paths, motion systems, vacuum, and refrigeration.
• Review and approve system-level specifications and technical documentation.
• Support manufacturing, testing, FAT/SAT, and field deployments.

Collaboration and Technical Leadership

• Partner with quality, validation, supply chain, and manufacturing to ensure designs are buildable, testable, and serviceable.
• Participate in customer‑facing technical discussions and architecture reviews
• Act as a go‑to technical resource for system‑level questions and decisions

Required:

• Bachelor’s degree in Mechanical Engineering or related discipline.
• 8–12+ years developing complex pharmaceutical, biotech, or regulated process equipment.
• Experience integrating mechanical, controls, and process subsystems.
• Working knowledge of GMP-regulated environments, including FDA, ISPE, ASME, and ASTM expectations.
• Strong communication skills across technical and non-technical stakeholders.

Preferred:

• Direct experience with aseptic fill-finish and/or lyophilization systems.
• Working knowledge of systems engineering methodologies, including requirements management and V-model practices.
• Experience leading or facilitating system-level FMEAs and formal design reviews.
• Proficiency with 3D CAD tools such as SolidWorks or Creo.
• Exposure to vacuum, thermal, refrigeration, and pressure-vessel-based equipment common in GMP environments

Competencies

• Technical aptitude and system-level thinking.
• Customer-centric consultative approach.
• Ability to drive standardization and repeatable processes.
• Excellent prioritization, organization, and problem-solving skills.

Why This Role Is a Career Accelerator

• True systems ownership instead of narrow component design
• High visibility with customers and internal leadership
• Opportunity to shape system architecture across multiple platforms
• Clear runway into senior systems, principal engineer, or technical leadership roles
• Work that directly supports life‑saving pharmaceutical and biotech therapies

Salary Range : $145k - $175k