POSITION OBJECTIVE: Manages facility controls systems. Coordinates and assists engineering, design, construction, installation, and modification of facilities controls and network aspects specific to the facility control system as needed.
Essential Job Functions/Responsibilities
- Prioritizing, planning, developing, designing, and implementing projects to improve capacity and capabilities, while maintaining cGMP compliance.
- Assists with all projects large or small, capital expenditure projects, new construction and modifications / renovations to existing areas including production and future phase development related to the facility controls systems.
- Communicate with all maintenance personnel of the company to assure best acceptance and progress for plant engineering activities.
- Manage related improvement projects and future construction phases of plant development considering elements of Good Engineering Design in a pharmaceutical manufacturing facility.
- Collaborate with Engineering, Architects, construction project managers, validation, maintenance and quality in all stages of a project.
- Manage and document change control projects and documentation as it pertains to the facility controls systems and the areas impacted.
- Work with mechanical and architectural heavy construction teams including commercial and industrial applications. High medium and low voltage applications, control enclosures, network infrastructure, programming and process applications required.
- Daily maintenance and troubleshooting of facility controls systems and their associated networks, with a focus on alarm resolution; identification of corrective actions; documentation of normal activities, problem resolutions and corrective actions in the appropriate manner.
- Daily maintenance includes logical point monitoring (ex., I/O points), system hardware status monitoring (ex., servers, switches, device level rings), as well as trend data monitoring.
- Manages required repair/replacement, calibration, and maintenance of the connected field devices in a compliant manner while minimizing impact to facility operations.
- Configures and maintains security permissions within the facility controls systems; ensures that roles assigned to configured users allow appropriate actions within the operating environments.
- Ability to administer the factory controls systems in a 21 CFR Part 11 compliant environment.
- Document review to include progressive drawings, submittals and specifications as related to controls systems and related network infrastructure.
- Ability to review and assess construction schedules for schedule recovery, repairs, upgrades and applications.
- Off hour and weekend shutdowns, installations and preparations as needed must be considered.
- Other projects as may be assigned.
Required Education & Qualifications
- Bachelor’s degree in technology or software engineering; may consider candidates with equivalent industry experience in lieu of degree.
- Minimum of (5) years applicable experience in pharmaceutical, clean room and/or research and development in a regulated environment.
- Experience with utilities, construction, production, process control systems, networking, and PLC or IPC programming required.
- Strong knowledge and experience in low voltage wiring, cabling and switches and electrical applications is required.
- Proficiency in facility controls systems and related software applications, data historians, SQL database management, backup and archive applications.
- Strong understanding of clean rooms, ISO certified areas and the systems that support these areas; air balance and air pressurization; good understanding of process equipment, such as waste treatment, clean in place, and formulation equipment.
- Understanding of quality assurance and validation elements as they relate to construction and plant operations.
- Must be proficient in current construction management tools, such as Microsoft project, BIM 360, pull planning, costs control, AIA documents and spreadsheets.
- Strong communication skills and vendor management experience.
- Must have understanding of specific OSHA, DEC and EPA standards as they relate to the plant environment.
- Ability to write reports with excellent attention to detail and planning.
- Continuous Improvement experience a plus (LEAN, TPM).
- Proficient in Microsoft suite of software, computerized calibration and maintenance management applications, and mobile technology.
- Must be available for off hour and weekend hours for projects as needed.
Athenex is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics.
Athenex is committed to working with and providing reasonable accommodations to individuals with disabilities. If you need a reasonable accommodation because of a disability for any part of the employment process, please notify HR and let us know the nature of your request and your contact information.