Developing and Manufacturing your Cell Therapies from Benchtop to Bedside.
Job Summary
Cellipont Bioservices is growing, and we are looking for a Automation Engineer II who believes in the potential of bridging client's discoveries to patient cures and who wants to challenge the status quo and take Cellipont and its clients to the next level.
The Automation Engineer II will be part of a team reporting to the Manager of Engineering and will provide key support for various manufacturing, quality and research automated systems, support capital projects for facility expansion, ensuring new equipment are integrated to automation infrastructure, administrating, troubleshooting and supporting manufacturing operations equipment, and ensure compliance with quality systems. This role will be responsible for trouble-shooting challenging equipment / automation issues to improve manufacturing performance (e.g. yield improvements, etc.) and maintaining the automation systems in compliance with cGMPs.
The Automation Engineer II will have the opportunity to lead projects in the deployment of new processes and IT capabilities. This individual will lead automation-related investigations into Quality Event Reports and implement the necessary corrective actions. Initial responsibilities include working with the startup team and providing technical leadership in fulfilling the automation requirements for a new state-of-the-art GMP Manufacturing facility for Cell Therapy. The Automation Engineer is responsible for partnering with Quality Assurance and Manufacturing groups in maintaining compliance with cGMP requirements.
The Role
- Experience working in a GMP-regulated industry or supporting computerized systems in a regulated environment is preferred.
-
Apply applicable computerized-system and data-integrity requirements, including 21 CFR Part 11, EU Annex 11, GAMP 5 principles, and ALCOA+ expectations.
-
Serve as a Subject Matter Expert for the design, planning, implementation, and lifecycle management of the Building Automation System, Environmental Monitoring System, and other facility automation systems.
-
Support the installation, configuration, integration, commissioning, qualification, operation, and retirement of computerized and automated systems used in GMP manufacturing, laboratory, and facility environments.
-
Administer and support OT infrastructure, including industrial computers, servers, virtual machines, network switches, communication gateways, PLCs, field devices, instrumentation, and system interfaces.
-
Support OT cybersecurity activities, including patch management, endpoint protection, vulnerability remediation, network segmentation, system hardening, and coordination with Information Technology and cybersecurity personnel.
-
Develop and maintain Automation-owned processes, including system administration, user access management, periodic account reviews, data backup and restoration, configuration management, system monitoring, and disaster recovery.
-
Provide on-floor technical support for GMP manufacturing activities, including troubleshooting automation systems, instrumentation, communication networks, system interfaces, and equipment-related issues.
-
Collaborate with Process Engineering, MS&T, Validation, Quality, Manufacturing, Facilities and Engineering, and Information Technology during technology transfers, client onboarding, and implementation of new manufacturing, laboratory, and facility equipment.
-
Evaluate automated and computerized systems and develop strategies for system expansion, replacement, upgrades, reliability, data integrity, security, performance, and long-term stability.
-
Lead or support investigations of automation anomalies, system failures, alarms, communication issues, and data integrity concerns, including root-cause analysis and corrective and preventive actions.
-
Support deviations, change controls, CAPAs, risk assessments, qualification activities, and other quality-system records associated with computerized and automated systems.
-
Review automation specifications, qualification documents, maintenance records, system drawings, configuration records, and SOPs to ensure compliance with GMP, safety, cybersecurity, environmental, and data integrity requirements.
-
Maintain technical documentation, including system architecture and network diagrams, configuration records, asset inventories, backup records, access records, maintenance procedures, and troubleshooting guides.
-
Participate in regulatory inspections, client audits, internal audits, and training programs involving automated and computerized systems.
-
Identify and implement process, equipment, and automation improvements that increase efficiency, reliability, compliance, and system availability.
-
Provide technical support for business-area applications and coordinate issue resolution with system owners, vendors, Information Technology, Quality, and other stakeholders.
-
Perform other duties as assigned and provide scheduled or emergency on-call support outside normal business hours, including nights and weekends.
The Candidate
-
Bachelor's Degree in Engineering (preferably but not limited to automation, electrical, chemical, and mechanical), information technology, science or related field)
-
Minimum of 2 year's direct industry experience in an Automation role supporting regulated equipment
-
Effective leadership, interpersonal and communication skills (written and oral) are required
-
A working knowledge of the regulatory requirements for pharmaceutical applications
-
Background in Allen BradleySiemens PLC, SCADA, Batch Operations (S88/S95), IT, and single use OEM equipment
-
Experience in Process Data Analytics
-
Creative thinking, detail orientation, manual dexterity
-
Contribute at an individual level as well as part of an organized team in a fast-paced environment
-
Intermediate knowledge of Microsoft Office products, particularly MS Excel and Outlook.
Work Environment
-
Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities
-
Ability to work off-shift and extra hours as required
-
WeekendsHolidays as required
Position Benefits
-
Opportunities for career growth within an expanding team
-
Defined career path and annual performance reviewfeedback process
-
Cross-functional exposure to other areas within the organization
- Robust benefit package designed for unique HealthWellness needs, including coverage for your furry family members
-
401K strong employer match
- Tuition Reimbursement
-
Employee Referral Bonuses
-
Flexible work schedules and PTO based on role/level, increasing 1 PTO day each year and paid holidays
-
Gain experience in the cutting-edge cell therapy space
"At Cellipont Bioservices, we look for candidates with an innate desire to serve. Our "family" approach ensures you will get the mentorship you need to develop a satisfying career here!"
Notice to Agency and Search Firm Representatives
Cellipont Bioservices is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Cellipont Bioservices employee by a third-party agency and/or search firm without a valid writtensigned search agreement, will become the sole property of Cellipont Bioservices. No fee will be paid if a candidate is hired for this position because of an unsolicited agency or search firm referral. Thank you.
