Senior Automation Engineer, Delta V

Description

The company is expanding its manufacturing capacity with a $2 billion investment in a new facility for innovative biologic medicines in oncology, immunology, and neuroscience.

The site's Delta V systems are being designed and maintained for the new facility, which is planned to be highly automated, with data flowing from raw material receipt through to disposition of the drug substance.

Data from each production stage will be shared across business and control systems, including multivariate analysis for predictive process control and disposition support.

The role is in Supply Chain Engineering, within Automation Engineering, in the Scientific/Technology category.

The team is in Wilson, North Carolina, United States of America.

Responsibilities

• Lead the Automation team's deliverables across projects and beyond.
• Take part in project execution as a team member, or lead large multi-project programs.
• Build global standards and join standardization teams.
• Represent execution systems in site business planning.
• Carry out or lead system changes and improvements.
• Carry out or lead validation work.
• Confirm that site and global standards are met.
• Lead risk assessments and support GMP audits.
• Make sure sound engineering principles are applied to all tasks.
• Deliver and run the site's Delta V strategy.
• Use your experience to find ways to improve the site's validation practices.

Requirements

• A minimum of a BS degree in Engineering, IT, Science, or a related field.
• At least 6 years in manufacturing, biopharmaceutical, or pharmaceutical work, or an equivalent mix of education and experience.
• Deep expertise in Emerson Delta V, including infrastructure and hardware.
• MES experience, preferably Werum PAS-X, and DeltaV Batch Control experience.
• Knowledge of industrial automation networks and their communication protocols.
• Understanding of ISA S95 and S88 and how they apply across the global supply chain.
• Understanding of OSI PI Historian.
• Proven experience in an automation or IT role in a pharmaceutical or GMP-regulated manufacturing setting.
• Preferred: knowledge of cGMP rules for computer system validation, including 21 CFR Part 11 and EU GMP Annex 11.
• Preferred: process knowledge for upstream, downstream, and bioprocessing support functions.
• Preferred: experience supervising or managing people and resources.
• Preferred: proven understanding of GAMP 5 and other recognized industry methods.
• Preferred: understanding of S95 level 4 systems, such as ERP, quality systems, data warehouses, and CDL.
• Preferred: project management certification or experience.
• Preferred skills: Artificial Intelligence (AI), Controls Compliance, Critical Thinking, Industrial Robotics, Industry Analysis, Innovation, Lean Supply Chain Management, Machine Learning (ML), Management Systems Implementation, Organizing, Problem Solving, Project Management, Prototyping, Robotic Automation, Science, Technology, Engineering, and Math (STEM) Application, Smart Systems, Technologically Savvy

Conditions

Travel may be required at times to support startup activities, based on functional needs and project timelines, which can mean frequent trips and short stays with vendors, sister companies, or partners.

In steady state, travel is expected to be under 10%.

The company is committed to an inclusive interview process and will make accommodations for applicants with disabilities on request.

Benefits

• Support for employee health and wellbeing across career and life, described on the company's careers site.