Automation Engineer II

Job Summary

Cellipont Bioservices is growing and seeks an Automation Engineer II to join our team. This role will bridge client discoveries to patient cures by supporting manufacturing, quality, and research automated systems, leading projects, and ensuring compliance with cGMPs.

About the role

The Automation Engineer II will provide key support for various manufacturing, quality, and research automated systems, support capital projects for facility expansion, and ensure new equipment is integrated into the automation infrastructure. They will troubleshoot equipment and automation issues to improve manufacturing performance and maintain compliance with quality systems.

Responsibilities

• Provide technical leadership in fulfilling automation requirements for a new GMP Manufacturing facility for Cell Therapy.
• 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.
• Evaluate automated and computerized systems and develop strategies for system expansion, replacement, upgrades, reliability, data integrity, security, performance, and long-term stability.
• 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.
• 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.

Requirements

• Bachelor's Degree in Engineering (preferably but not limited to automation, electrical, chemical, and mechanical), information technology, science or related field.
• Minimum of 2 years' direct industry experience in an Automation role supporting regulated equipment.
• Effective leadership, interpersonal and communication skills (written and oral).
• A working knowledge of the regulatory requirements for pharmaceutical applications.
• Background in Allen Bradley & Siemens PLC, SCADA, Batch Operations (S88/S95), IT, and single use OEM equipment.
• Experience in Process Data Analytics.
• Creative thinking, detail orientation, manual dexterity.

Qualifications

• Intermediate knowledge of Microsoft Office products, particularly MS Excel and Outlook.
• 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.
• Weekends & Holidays as required.

Benefits

• Position benefits opportunities for career growth within an expanding team.
• Defined career path and annual performance review & feedback process.
• Cross-functional exposure to other areas within the organization.
• Robust benefit package designed for unique Health & Wellness 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.