Automation Engineer, GMP

About the role

The Automation Engineer is responsible for administration and management of the site’s automation systems, including Supervisory Control and Data Acquisition (SCADA) system, PLCs, notification systems and computerized QC Lab instruments. The scope of the responsibilities includes the initial installation, ongoing maintenance, periodic back-up, change control, validation, and retirement of systems.

Responsibilities

• Work closely with stakeholders to understand and fulfill system requirements and improve the quality of automated processes.
• Collaborate with stakeholders, including Area Managers, System Owners, and System Users to ensure successful onboarding, use and retirement of automation systems.
• Create and improve Administration SOPs of automation systems
• Maintain up-to-date knowledge of current technology trends, programming languages, and automation best practices for bioprocess equipment including single-use bioreactors, chromatography controllers, ultrafiltration skids, and QC instruments.
• Recommend and integrate new bioprocess equipment and Process Analytical Technologies (PAT).
• Liaison with Business, Quality Assurance, Managed Services, and IT to coordinate the Change Request processes

Qualifications

• Expertise in IT Networking and industrial automation systems, such as Rockwell Automation (Allen Bradley RS Logix), Wonderware Archestra platform, TopView, Vaisala ViewLinc, Unicorn software, DeltaV, various Repligen and Thermo Scientific instruments is a plus.
• Bachelor of Science in Electrical Engineering, Computer Science, IT, Engineering, or related field of study with at least 5-7 years of related experience that provides direct scientific knowledge of automation systems operation and validation principles for computerized biologics production systems.
• Proven experience as an IT Automation Engineer or similar role.
• Direct knowledge of the biologics process equipment, SCADA/control systems, and supporting IT networking infrastructure.
• Expertise in scientific / technical subject areas – Equipment Qualification, Computer System Validation, SCADA system architecture, Biotech Process Equipment/Systems.
• Proficient in use of electronic systems, such as Microsoft Office, various specialized software including process documentation Veeva Vault, Material Management (SAP), Computerized Maintenance Management System (Maximo), Building Automation System (BAS).
• Knowledge of domestic / international regulatory guidelines / compendia and industry standards (FDA, ICH, USP and EMEA guidelines) for validation of computerized equipment and automation systems, including but not limited to 21 CFR Part 11, EU Eudralex Annex 11 and GAMP 5.
• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
• Comfort with collaboration, open communication, reaching across functional borders and being proactive.
• A strong focus on business outcomes.
• Ability to prioritize and juggle multiple concurrent projects and day-to-day requests

Benefits

• Medical, dental, and vision insurance
• 401(k) retirement plan with a company match that vests fully on day one
• Paid parental leave after just three (3) months of employment
• Paid time off policy that includes vacation time, personal time, sick time, floating holidays, and company holidays
• Flexible spending and health savings accounts
• Life and AD&D insurance
• Short- and long-term disability coverage
• Legal assistance
• Supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance
• Commuter benefits
• Well-being initiatives
• Peer-to-peer recognition programs

Pay

$90,000 - $120,000 annually

Schedule

Fully onsite in Pennington, New Jersey