| Location | New Jersey, NJ |
Job Title: Technical Process Specialist / System Process Expert
Location: Packanack Lake, NJ
Experience Required: 5+ Years
Department: Manufacturing / Automation / IT Systems
Job Summary
The Technical Process Specialist serves as the subject matter expert (SME) for key manufacturing and quality systems such as MES, SCADA, LIMS, and Track & Trace. This role ensures that these systems operate efficiently, remain compliant with regulatory requirements, and continuously evolve to meet business and technological advancements. The specialist acts as a bridge between IT, Engineering, Operations, and Quality teams to drive system performance, compliance, and process improvements.
Key Responsibilities
Serve as the primary knowledge authority for assigned systems, processes, or equipment (e.g., MES, SCADA, LIMS, Track & Trace Systems like ACG, Systech, e-Logbooks).
Understand end-to-end workflows, system integration points, and regulatory requirements impacting the system or process.
Provide technical guidance during system upgrades, configuration changes, and process optimizations.
Collaborate with IT, Engineering, Operations, and Quality teams to ensure smooth deployment of new systems or enhancements.
Provide advanced troubleshooting support and resolution for critical technical or process-level issues.
Participate in vendor meetings to evaluate new solutions, assess compatibility, and support implementation.
Ensure all systems and processes comply with regulatory standards (FDA, cGMP, 21 CFR Part 11, etc.).
Develop, review, and maintain SOPs, work instructions, validation protocols, and training materials.
Support internal and external audits, providing documentation and detailed responses as required.
Conduct end-user training sessions to ensure understanding of system functionalities and compliance expectations.
Mentor junior team members and facilitate cross-training across departments.
Maintain a central knowledge base for troubleshooting guides, FAQs, and best practices.
Analyze system and process performance to identify efficiency gaps, data integrity risks, and improvement opportunities.
Lead root cause analyses (RCA) and implement corrective and preventive actions (CAPA) for recurring issues.
Stay updated with industry trends, new technologies, and regulatory changes to recommend innovative solutions.
Required Qualifications
Bachelor's degree in Engineering, Information Technology, Life Sciences, or related field (or equivalent experience).
Minimum 5 years of experience in manufacturing, process automation, or regulated environments.
Proven expertise in at least one system (MES, LIMS, SCADA, or Track & Trace).
Strong understanding of cGMP, FDA, and global regulatory compliance.
Excellent analytical, problem-solving, and communication skills.
Preferred Skills
Experience with system integrations (ERP, MES, WMS, LIMS, SCADA, Track & Trace).
Prior experience working in multi-site, cross-functional teams.
Knowledge of data integrity principles, audit trail management, and system validation.
Key Competencies
Expert-level understanding of assigned systems and processes.
Strong leadership and collaboration abilities.
High attention to detail and compliance focus.
Proactive mindset with a drive for continuous improvement and innovation.