Sr. Engineer II, Automation - PI Automation
About The Position
About This Role We are excited to welcome a Senior Automation Engineer II to our team, where you will play a pivotal role in supporting automation systems crucial to our biopharmaceutical manufacturing processes. As part of this dynamic team, you'll ensure the seamless operation of PI, Infobatch, and other data systems, driving the digital infrastructure that underpins our process understanding and operational excellence. With your expertise, you will manage system lifecycles, collaborate across diverse teams, and provide support for data acquisition and monitoring platforms. Your contributions will be instrumental in advancing our manufacturing execution and compliance, positioning you as a vital asset in our organization. What You’ll Do Provide technical ownership, administration, and support of PI, Infobatch, and other data systems across development and GMP manufacturing environments. Collaborate with cross-functional teams—including Process Development, Engineering, Manufacturing, Quality, and IT—to integrate automation platforms into broader business and compliance workflows. Lead or support projects involving data acquisition system upgrades, software validation, alarm monitoring improvements, and batch reporting enhancements. Ensure system reliability, data integrity, and compliance with 21 CFR Part 11 and other applicable regulatory requirements. Lead troubleshooting and root cause investigations related to system and equipment data capture, alarms, and reports. Support development and maintenance of user requirements, functional specifications, system validation, and standard operating procedures. Serve as a subject matter expert (SME) for audits and inspections related to automation systems. Mentor junior engineers and provide technical guidance on best practices and system usage. Who You Are You are a meticulous professional with a strong foundation in automation/manufacturing systems engineering, particularly in biopharmaceutical settings. Your analytical mindset and problem-solving skills empower you to tackle complex challenges independently. You thrive in collaborative environments, easily engaging with diverse teams to achieve shared goals. Your dedication to operational excellence and compliance ensures that systems run smoothly and efficiently. A natural mentor, you enjoy guiding others and sharing your technical expertise to foster growth within your team.
Requirements
- B.S. in Engineering
- 6+ years of experience working with manufacturing systems in biopharmaceutical manufacturing environments.
- Hands-on experience with: PI (tag configuration, Asset Framework, visualization tools such as PI Vision)
- Solid understanding of GMP regulations and experience working in validated systems.
- Experience supporting system lifecycle management, including upgrades, backups, disaster recovery, and cybersecurity controls.
- Excellent troubleshooting skills and ability to work independently in a fast-paced environment.
Nice To Haves
- Experience working with automation systems such as MES (Syncade), DCS (DeltaV), and SCADA (Rockwell) platforms.
- Infobatch (batch data reporting, SFO/recipe integration)
- TopView (alarm notification setup and system management)
- Knowledge of IT/OT networking and virtualized infrastructure (Nutanix).
- Experience with scripting or programming (e.g., VBA, Python, SQL) is a plus.
Responsibilities
- Provide technical ownership, administration, and support of PI, Infobatch, and other data systems across development and GMP manufacturing environments.
- Collaborate with cross-functional teams—including Process Development, Engineering, Manufacturing, Quality, and IT—to integrate automation platforms into broader business and compliance workflows.
- Lead or support projects involving data acquisition system upgrades, software validation, alarm monitoring improvements, and batch reporting enhancements.
- Ensure system reliability, data integrity, and compliance with 21 CFR Part 11 and other applicable regulatory requirements.
- Lead troubleshooting and root cause investigations related to system and equipment data capture, alarms, and reports.
- Support development and maintenance of user requirements, functional specifications, system validation, and standard operating procedures.
- Serve as a subject matter expert (SME) for audits and inspections related to automation systems.
- Mentor junior engineers and provide technical guidance on best practices and system usage.
Benefits
- Medical, Dental, Vision, & Life insurances
- Fitness & Wellness programs including a fitness reimbursement
- Short- and Long-Term Disability insurance
- A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
- Up to 12 company paid holidays + 3 paid days off for Personal Significance
- 80 hours of sick time per calendar year
- Paid Maternity and Parental Leave benefit
- 401(k) program participation with company matched contributions
- Employee stock purchase plan
- Tuition reimbursement of up to $10,000 per calendar year
- Employee Resource Groups participation
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
5,001-10,000 employees
