Project Management: 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.
Production Support: 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.
Designs and/or implements modifications to the existing manufacturing equipment that will improve the operational efficiencies.
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.
Other duties as assigned.
Qualifications
Bachelor’s degree in engineering or related field required.
Minimum 4 years’ experience in Automation / Controls Engineering.
Previous work experience in a sterile manufacturing environment preferred.
Experience with robotics, AI, and machine learning.
Experience with project management.
Knowledge, Skills, and Abilities
Mastery of a variety of automation software applications. Software applications include but are not limited to the Allen-Bradley RSLogix portfolio, Allen-Bradley RSView, GE Proficy SCADA/HMI iFix. The following are highly desired:
Exemplary knowledge of discrete machine control; AB Safety PLCs, Gearboxes, Safety Circuits, Pneumatics, etc.
Mastery of Data Historian
Ability to perform assigned tasks carefully and on schedule according to standard operating procedures and supervisor’s instructions.
Ability to work with people at all levels of the organization.
Ability to perform complex math functions, compute ratios, rates, and percentages.
Ability to draw and interpret graphs and charts.
Ability to solve practical problems and deal with a variety of concrete variables in situations where limited standardization exists.
Ability to interpret a variety of instructions furnished in written, oral, diagram or schedule form.
Excellent verbal communication and presentation skills required.
Proficiency with Microsoft Office applications.
Proficiency in maintaining automation equipment.
Solid understanding of computer programming and software development.
Ability to troubleshoot equipment and perform complex system tests.
Strong leadership and problem-solving skills.
Strong analytical skills.
Ability to keep up with the latest technologies.
Physical Demands and Work Environment
The physical demands and work environment described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this Job, the employee is regularly required to use hands to finger, handle, or feel; reach with hands and arms; talk or hear and smell. The employee is frequently required to sit. The employee is occasionally required to stand; walk and stoop, kneel, crouch, or crawl. The employee must regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus. The noise level is moderate to noisy. Occasionally, employee may be exposed to airborne particles and fumes. Occasionally, employee may be exposed to chemicals. Must have the ability to wear PPE as required. Employee occasionally may be exposed to moving mechanical parts and vibration.
