The Controls Specialist is responsible for supporting Automation Engineer(s) in developing, maintaining, and troubleshooting equipment, facility, and utility (EFU) control systems. The Controls Engineer is quality-centered and follows company standard operating procedures (SOPs) geared toward FDA and other applicable regulations and in-line with current good manufacturing practices (cGMPs).
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Develop specifications for, configure, install, maintain, and troubleshoot common control components including, but not limited to, PLCs, HMIs, and VFDs.
- Respond to end-user requests for support, sometimes on short notice or outside of normal business hours.
- Adhere to project schedules.
- Train end user, quality, and maintenance personnel on controls-related procedures.
- Assist in the implementation and administration of EFU software packages (ex. SCADA).
- Identify and implement quality system improvements when gaps are identified through audits and departmental reviews.
- Foster an environment of cooperation and teamwork both within the department and between departments.
- When necessary, coordinate external vendors and/or contractors to perform work.
- Additional duties as assigned.
- Associates degree in an applicable automation, controls, or engineering discipline with 3+ years professional experience in an automation/controls-centered position.
5+ years professional experience in an automation/controls-centered position.
- Performance of Essential Duties and Responsibilities for all EFU unit operations or groupings (ex. suite- or facility-level) with a high degree of independence.
- Excellent written and verbal communication skills.
- Ability to adapt to changing regulatory, client, and company requirements; new technologies; and shifting priorities.
- Ability to use all available resources (personal experience, documentation, technical support, etc.) to quickly develop a working understanding of unfamiliar systems so that effective support can be provided.
- Ability to travel (typically <5%) for training and/or EFU testing.
- Ability to work flexible hours and inconsistent schedules, occasionally on short notice, as necessary to meet production demands and timelines.
- Strong organizational skills.
- Ability to think strategically and translate into action.
While performing the duties of this Job, the employee is regularly required to stand and talk or hear. The employee is frequently required to use hands to finger, handle, or feel and reach with hands and arms. The employee is occasionally required to walk; sit; climb or balance and stoop, kneel, crouch, or crawl. The employee must occasionally lift and/or move up to 50 pounds.
Work environment will vary to include:
office atmosphere, clean room aseptic manufacturing areas, mechanical utility spaces, walk in cold/warm/freezer rooms, warehouse, and outside (ex. roof). Environmental conditions will include moderate temperature fluctuations, moderate humidity, and moderate noise levels. Close proximity to hazardous utilities, fumes, or chemicals is possible. While performing the duties of this job, the employee is occasionally exposed to moving mechanical parts; toxic or caustic chemicals.