Smith & Nephew-posted 4 months ago
Full-time • Mid Level
Hybrid • Fort Worth, TX
5,001-10,000 employees
Miscellaneous Manufacturing

The Automation Engineer 2 will provide support towards pharmaceutical manufacturing equipment, critical utility systems and facility, for technical GMP requirements toward the successful installation and start-up of a new Biotherapeutic Manufacturing Area including manufacturing support of sustained operations while in a production state. This role is accountable for determining and delivering automation solutions to an approved budget and schedule commitments while meeting required GMP and Part 11 standards, thus will be required to follow an established project plan structure and lead/contribute to delivering on-budget, on-time, along with the capability to receive FDA and Health Canada Approvals. Job requirements for equipment will include, but not limited to: URS development, FAT execution, installation support, commissioning / validation, SOP development, Preventive Maintenance job plan development, production support, and efficiency improvement initiatives. This role will require the incumbent to lead investigator for authoring change control documentation, authoring / supporting deviations / manufacturing non-conformances and CAPAs, and authoring risk assessments.

  • Function as an Automation Subject Matter Expert (SME) to equipment or systems regarding troubleshooting operations and/or changes to improve efficiency.
  • Actively involved in daily operations when required to meet schedules or to resolve complex problems.
  • Routinely audit the operational performance and regulatory compliance of a moderate number of equipment items or systems of significant complexity.
  • Work with multiple departments in developing requirements and recommendations for system modifications.
  • Guide and mentor junior team members on automation best practices and methodologies.
  • Technical translation and execution of all validation requirements for new and/or modified manufacturing, and utilities equipment/systems.
  • Ensure equipment and utility systems are available for GMP Manufacturing, in a state of compliance, and reliably performing to their validated function.
  • Participate in Factory Acceptance Testing (FAT), Commissioning of new equipment, IQ/OQ/PQ, Validation Summary Reports, Part 11 Compliance.
  • Develop and lead one or more projects, ensuring technical alignment with the commercial and marketing strategy for the project.
  • Manage the project and project team to key milestones and targets.
  • Drive the development and operational delivery of the project plan in accordance with Project Management best practices.
  • Manage Project risks, budget, schedule variance, and change management for the project.
  • Complete capital requests and purchase orders as needed to support projects.
  • Generate any associated quality documentation requirements such as SOPs, Change Controls, URS, Room Specification, Validation protocols, Job Plan instructions, Non-Conformances, and CAPAs.
  • Perform Risk Assessments and/or Gap assessments for equipment, process, method, and/or facility tech transfers.
  • Bachelor's degree required in engineering or related field.
  • Minimum 3 years of experience in a Pharmaceutical/Biotech environment or a minimum of 1 year within the Automation Engineer 1 role with consistent performance.
  • Strong working knowledge and experience of PLC's, HMI's, and SCADA systems.
  • Demonstrated experience in Project Management of automation solutions with proven results.
  • EIT/PE License preferred.
  • Lean/Six Sigma certification highly desired.
  • PMP certification a plus.
  • 401k Matching Program
  • 401k Plus Program
  • Discounted Stock Options
  • Tuition Reimbursement
  • Flexible Personal/Vacation Time Off
  • Paid Holidays
  • Flex Holidays
  • Paid Community Service Day
  • Medical, Dental, Vision, Health Savings Account (Employer Contribution of $500+ annually)
  • Employee Assistance Program
  • Parental Leave
  • Fertility and Adoption Assistance Program
  • Hybrid Work Model (For most professional roles)
  • Hands-On, Team-Customized, Mentorship
  • Discounts on fitness clubs, travel and more!
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