Automation Engineer ; Fort Worth, TX

Position: Automation Engineer 2 (Fort Worth, TX)
** Automation Engineer 2 (Fort Worth, TX)
**** Life Unlimited.
** At Smith+Nephew we design and manufacture technology that takes the limits off living.

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. Required to be 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.

Guiding and mentoring 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, ensuring equipment and utility systems are available for GMP Manufacturing, in a state of compliance, and reliably performing to their validated function. Active participation of Factory Acceptance Testing (FAT), Commissioning of new equipment, IQ/OQ/PQ, Validation Summary Reports, Part 11 Compliance, etc, as required for Manufacturing, Utilities, and Computerized systems.
* Develop and lead one or more projects, ensuring technical alignment with the commercial and marketing strategy for the project and managing the project and project team to key milestones and targets. Drives the development and operational delivery of the project plan in accordance with Project Management best practices, Smith+Nephew SOPs and Guidance Documents, and the product profile. Manages Project risks, budget, schedule variance, and change management for the project.

Reports to executive management as appropriate. Completes 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. Will also perform Risk Assessments and/or Gap assessments for equipment, process, method, and/or facility tech transfers.
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* Education:

*** Bachelor's degree required in engineering or related field
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* Certifications:

*** EIT/PE License preferred.
* Lean/Six Sigma certification highly desired.
* PMP certification a plus
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* Experience:

*** 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.
** Knowledge:
*** Working knowledge in aseptic manufacturing and fermentation processes.
** Competences:
*** Design documentation, Equipment manual, and P& (in the English language)
* Adherence to Quality Systems and Good Manufacturing Practices…