Automation Controls Engineer IIBuild your future at Curia, where our work has the power to save lives Curia is a global contract development and manufacturing organization (CDMO) with over 30 years of experience partnering with pharmaceutical and biotech companies to provide life-saving treatments to patients. At Curia, we are on a mission to advance our customers' therapies from curiosity to cure and ultimately to improve patients' lives. The Automation Controls Engineer II is responsible for maintaining the control and data acquisition systems of the manufacturing, packaging, and support equipment at the site, including Supervisory Control and Data Acquisition (SCADA) systems, PLC (Programmable Logic Controllers), and Human Machine Interface (HMI) devices. Provides technical review and counsel on a variety of technical issues related to his/her expertise, and constantly looks for opportunities related to efficiency, reliability, and obsolescence, to identify business opportunities aligned with the site and company goals.
Essential Duties and Responsibilities:- Maintain, troubleshoot, and improve automation and data acquisition systems including SCADA, PLC, and HMI devices used in manufacturing, packaging, and support operations.
- Diagnose and resolve control system issues related to automated equipment, supporting both corrective and preventative maintenance activities.
- Collaborate with cross-functional teams including operations, maintenance, quality, validation, and engineering to address automation-related issues and improve system performance.
- Coordinate and support external contractors or vendors working on automation systems, equipment, facilities, or utilities.
- Participate in investigations involving automated equipment deviations, assisting with root cause analysis and implementation of corrective and preventive actions.
- Initiate and prepare engineering documentation and change control records related to automation systems, including SOPs, preventative maintenance procedures, and technical documentation.
- Perform PLC and HMI programming, configuration, and modifications to support equipment improvements, system upgrades, and troubleshooting.
- Maintain and update automation system documentation, including engineering drawings, system architecture documentation, and software records.
- Identify opportunities to improve automation system performance, reliability, and maintainability.
- Support equipment upgrades, automation integration activities, and new equipment implementation.
- Participate in Validation and Computer Systems Validation activities to ensure compliance with regulatory requirements and internal procedures.
- Read and interpret SOPs and technical documentation to ensure compliance with company and regulatory standards.
- Maintain required training and certifications.
- Read/interpret SOPs to ensure compliance
- Maintain up to date trainings
- Other duties as assigned
- Education and/or Experience:
- Bachelor's Degree in Electrical Engineering or relevant field
- Minimum of three (3) years' experience in automation integrationPLC and HMI experience (ie. Rockwell, Allen Bradley, Siemens, and Simatic)
- Demonstrated experience troubleshooting and resolving complex control system issues and performing equipment upgrades in production maintenance
- Experience in system automation upgrades and production support, preferred
Experience in the Medical Device or Pharmaceutical regulated industry, preferredDetailed Knowledge of cGMP and regulatory requirements relating to process automation including the GAMP V model, preferredDetailed knowledge of the 21 CFR Part 11 and Annex 11 requirements for automated systems, preferred
Supervisory Responsibilities:
This role does not have supervisory responsibilities, yet it may involve mentoring, guiding, and advising.
Language Skills:
The ideal candidate should have the ability to read and interpret various documents, such as safety instructions, standard operating procedures, technical procedures, and governmental regulations. Additionally, they should possess strong written and verbal communication skills, along with effective presentation skills.
Mathematical Skills:
- Proficient in executing arithmetic operations including addition, subtraction, multiplication, and division across various units of measurement, employing whole numbers, fractions, decimals, and percentages. Candidates must possess a strong grasp of algebraic and geometric principles.
- Reasoning Ability:
- Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
- Computer Skills:
The ideal candidate will possess a strong technical foundation and proven capability in effectively utilizing diverse software tools to streamline the organization's daily functions. Essential skills encompass adeptness in manufacturing and internet software, alongside proficiency in Microsoft Office tools including PowerPoint, Excel, Word, and Outlook.
Other Skills and Abilities:- Provides guidance and mentorship to team members
- Fosters a collaborative and positive work environment
- Champions change
- Promotes a safe and healthy work environment by actively identifying and addressing potential hazards, following established safety protocols, participating in safety training programs, and fostering a culture of awareness and responsibility among team members
- Demonstrates strong attention to detail
- Excellent communication skills, both verbal and written
- Ability to organize a time to successfully manage multiple projects and priorities
- Ability to read, understand, interpret and implement technical writing and instructions
- Effective interpersonal relation skills, while maintaining the adaptability to achieve company goals
- Verbally expresses ideas and facts in a clear, logical, concise, and accepted grammatical style
- Knowledgeable with regulatory agencies (OSHA, EPA, FDA, JP, EU, etc.)Prefer knowledge in the design of building management systems and cleanroom aseptic facilities
- Able to read and understand the point-to-point control schematics and sequence of operations
Other Qualifications:- Must pass a background check
- Must pass a drug screen
- May be required to pass Occupational Health Screening
- May be required to obtain and maintain gowning certification
- May be required to obtain and maintain media qualification
- May be required to wear a respirator
Physical Demands:
The physical demands 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. The essential physical demands will vary for each Curia position. All positions may require regular or occasional lifting, pushing and pulling up to 10 pounds, frequently; up to 25 pounds occasionally; and up to 50 pounds infrequently. Additionally, all positions entail regular sitting, standing and reaching, with some roles requiring prolonged periods of time for each activity. Visual acuity, both close and distant, along with depth perception is necessary in each role, with or without corrective lenses. Please note that employees are prohibited from wearing contact lenses in work areas with exposure to cleaning agents. Hand and finger dexterity are integral to all positions, with specific activities varying from typing to manipulating maintenance tools or operating keypads, switches, and buttons. Occasional stooping, kneeling, twisting, crouching, crawling and balancing are also part of each position's physical requirements. Certain roles may involve climbing and working at elevated heights as well.
Work Environment:
The work environment characteristics, described below, are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The working environments will vary for each Curia position. The employee may be required to work in an office, manufacturing, or warehouse environment. The office environment is designed for comfort and productivity, with room temperature settings maintained for optimal working conditions. It is common to hear conversational noise in the background. The pharmaceutical manufacturing environment is sterile. Therefore, aseptic gowning is required. Personal protective equipment (nitrile gloves, clean room socks, face-shields, safety glasses, aprons, steel-toed shoes and powered air purifying respirators) is necessary, depending upon the task at hand. The employee may be exposed to wet and/or humid conditions, confined areas, and refrigerator or freezer temperatures when working in a sterile environment. The warehouse environment is typically set at a controlled temperature but the employee may be exposed to refrigerator or freezer temperatures when retrieving materials. Some positions may occasionally be exposed to moving mechanical parts, elevated heights, airborne particles, electrical activities and vibration. In addition, some positions may work with or be
