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Mykelly is seeking a Sr. Automation Engineer in Morrisville, NC for 1st shift, on-site, 8:00 AM–5:00 PM. The role requires 5+ years in automation, preferably in a pharmaceutical/sterile manufacturing setting, with a focus on capital projects and process improvements.
Contract-to-Hire is preferred for speed; direct hire will be considered for the right candidate. The position involves leading automation projects, programming PLCs/SCADA/HMI, FAT/SAT activities, and maintaining compliant systems
Sr. Automation Engineer —Morrisville, NC | 100% On-Site
1st Shift, Monday–Friday, 8:00 AM–5:00 PM
At least 5 years’ experience, flexible Contract to Hire or Direct Hire
Salary negotiable.
Job Summary:
Our client in Pharmaceuticals has a new role, a Sr. Automation Engineer, due a retirement- critical and big shoes to fill! Contract to Hire would be ideal as it moves faster, however, the right person only opened to Direct Hire will be considered. Contract to Hire or Direct Hire, which is not, is a temporary role. The Automation Engineer will be accountable for driving results in a fast-paced environment by being responsible for multiple capital and process improvement related projects.
Automation Engineers are expected to hold both a project management and production support workload. The Automation Engineer’s primary responsibilities will center around:
Evaluating and implementing new ways to automate systems that drives efficiency and compliance.
Testing automation equipment and processes (driving FAT, SAT, and commissioning activities within the Engineering Department and aiding the Validation Department with qualification efforts).
Programming new automated components (i.e. door interlock systems, etc.).
Evaluating existing auto-generated reports for improvement and provide requirements for future auto-generated reports.
Maintain current automation systems to ensure all software is current and running on the appropriate platform.
Engineering responsibilities include developing user and design requirements, selecting equipment vendors or completing the technology design and equipment build in-house, managing the installation of automation while ensuring safety, and supporting the validation of the automated system for adherence to requirements, CGMPs, and intended system operation.
Support Maintenance Technicians in situations where troubleshooting or technology may fall outside of their area of expertise. Interact with production supervisors/managers to identify areas to improve equipment throughput, flexibility, quality, safety, and/or reliability. Implement automation solutions resulting from deviations, investigations and/or CAPA assignments. Composes Functional Requirement Specifications (FRSs) for new or upgraded utilities systems, compounding processes, and filling equipment.
Acts as engineering and technical lead for key plant projects.
Provides technical support for and leads safety and quality improvement initiatives.
Programs PLCs, HMIs, SCADA systems, and inspection systems.
Manages multiple capital projects concurrently.
Designs, installs, and supports the validation of the automated control system for new or upgraded utilities systems, compounding processes, and filling equipment.
Generates and revises standard operating procedures.
Leads Manufacturing Deviation investigations and applies good engineering practices to reduce the risk of repeat non-conformances.
Implements corrective and preventative actions to improve manufacturing’s operational efficiencies.
Performs risk assessment and risk mitigation activities using systematic tools.
Participates in internal discussions with internal customers to determine timing for project execution and sequencing of various project milestones.
Requests bids from contractors and suppliers by working with procurement group, recommends best provider.
Formalizes CAPEX document preparation and submission.
Maintains company reputation by complying with applicable federal and state regulations. Demonstrates company loyalty in relations with company personnel.
Maintains a safe, clean, and organized work environment free of safety hazards.
Ensures timely completion and compliance with cGMP and all other relevant company training requirements.
Client is a U.S-based contract development and manufacturing organization (CDMO) that supports pharmaceutical and biotech companies with drug development, analytical testing, and manufacturing services. Join- contribute to bringing medicines to patients while building experience in the life sciences industry. Help advance medicines from development toward patients by collaborating across a range of scientific and technical projects, all while building your skills.
This is an urgent opportunity to step into a critical engineering role and take ownership of automation projects that directly support reliable, compliant pharmaceutical manufacturing. You’ll lead meaningful plant improvements, partner with experienced teams, and help ensure essential medicines can be produced safely and efficiently. The role is intended to be long-term, with Contract-to-Hire preferred for a faster start; qualified Direct Hire candidates will also be considered.