Syner-G · 15 hours ago
Sr. Automation Engineer
Raleigh, NC
Full-time
Onsite
Senior Level
5+ years expSyner-G is a biopharma product development and delivery partner dedicated to enhancing the quality of life through innovative therapies. They are seeking a Sr. Automation Engineer to lead the oversight, documentation, and lifecycle management of automation systems, ensuring compliance and continuous improvement across client engagements.
HealthcareManufacturingPharmaceuticalHealth Care
No H1B
Responsibilities
Lead the development, maintenance, and review of automation system documentation including SOPs, design documents, DS, FS, CA, RTM, and RA
Oversee system lifecycle activities, periodic reviews, and audit readiness, ensuring alignment with regulatory expectations
Author, review, and execute complex validation documentation such as IOQs, engineering tests, protocols, and summary reports
Drive CSV and SDLC activities to ensure robust traceability, risk management, and compliance
Lead automation-related projects, including upgrades, remediation efforts, lifecycle initiatives, and system improvements
Develop and manage project plans, establish timelines, coordinate stakeholders, and track deliverables to ensure on-time execution
Facilitate cross-functional meetings, status reporting, and documentation to ensure alignment throughout the project lifecycle
Identify and mitigate project risks, escalating issues as needed to maintain schedule and quality
Assess automation workflows, system performance, and documentation processes to identify opportunities for optimization
Recommend and implement process improvements that enhance efficiency, compliance, and system reliability
Support continuous improvement initiatives across automation, quality, and facility operations
Perform advanced data reviews, including alarm rationalization, user access audits, and system performance evaluations
Own and manage automation change records, including impact assessments, stakeholder coordination, and documentation updates
Oversee and coordinate maintenance activities, work orders, and system enhancements across automation platforms
Collaborate with internal teams and external vendors to resolve complex system issues, support upgrades, and implement long-term solutions
Serve as a senior liaison between Facilities, Quality, IT, Operations, and external partners
Mentor and support junior and mid-level automation staff
Lead audit preparation efforts and ensure automation systems remain inspection-ready
Maintain strong GMP documentation practices and support regulatory inspections as a subject-matter expert
Qualification
Required
BS or MS in Engineering, Life Sciences, or a related technical discipline preferred
5-10 years supporting and leading automation initiatives within GMP-regulated environments
Strong project management experience including planning, execution, risk mitigation, and stakeholder management
Experience implementing process improvements within automation or technical operations
Strong experience with BAS/BMS, EMS, or process automation platforms such as Siemens Desigo, DeltaV, Rockwell, or PLC/SCADA systems
Extensive background in GMP documentation, validation, and CSV/SDLC processes
Demonstrated ability to lead complex technical efforts and manage cross-functional initiatives
Strong understanding of automation system architecture, control logic, alarm logic, and point configuration review
Advanced skill in writing, reviewing, and managing controlled documents and validation protocols
Strong communication, organization, leadership, and cross-functional coordination abilities
Ability to manage multiple high-priority tasks in a fast-paced, compliance-driven environment
Benefits
Market competitive base salary
Annual incentive plan
Robust benefit offerings
Generous flexible paid time off program
Company-paid holidays
Flexible working hours
Fully remote work options
Company
Syner-G
Syner-G is a Strategic Development & Delivery Partner™ to biopharma innovators.
201-500 employees
Funding
Current Stage
Growth StageLeadership Team
Ron Kraus
Chief Executive Officer
Prabu Nambiar
Founder, Board Member
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