Sr. Manager, Automation, Controls and Calibration

Changing lives. Building Careers.

Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what’s possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care.

The Sr. Manager of Automation, Controls and Calibration will report to the Director of Engineering and is directly Responsible for overall support of all controls/automation and calibration of equipment in CMC Buildings 105 and 109 related to manufacturing, ownership of the Building Monitoring System (BMS) in Buildings 105 and 109, the Jace system in B105 CMC, and all other control systems related to Facilities, Manufacturing and Labs. Such equipment includes but is not limited to:

Production Instrumentation • Rockwell PLCs • Panel View System • Rockwell Factory Talk • Modicon PLCs • McQuay Control systems • Motor Control Panels • AC/DC Variable Frequency Drives • System Development Life Cycle

REPORTING & MANAGEMENT SCOPE

SUPERVISION RECEIVED

Under direct supervision of the Director of Engineering

SUPERVISION EXERCISED

Direct Reports:

• Calibration Manager

• Automation and Control Engineers and Technicians

KEY RESPONSIBILITIES

- Lead the site calibration and metrology program supporting approximately 2,500 assets and over 3,000 annual calibration events.
- Define preventive maintenance activities for instrumentation and control equipment. Serve as a subject matter expert (SME) for automated manufacturing processes and facility systems.
- Assist Operations and Quality in day-to-day running and troubleshooting of automated manufacturing systems and laboratory systems.
- Provide support and mentoring to Automation and Control Engineers and Maintenance Technicians.
- Serve as a subject matter expert (SME) during project planning, design and implementation.
- Ensure that all cGMP automation equipment and systems have the minimum documentation as per the ISPE GAMP5 guidelines.
- Support the computer system validation activities for all cGMP automation equipment, including development of documentation as per the ISPE GAMP5 guidelines.
- Manage all documentation following Good Documentation Practices (GDP).
- Complete all assigned tasks following cGMPs, OSHA, EPA and other Federal and State regulations.
- Support automation team ownership of all automation Standard Operating Procedures (SOP)s and system drawings.
- Perform system administrator role, including managing system users.
- Perform annual system review for all automation systems.
- Provide system support during Non-Conformance (NC's) and Corrective Action Preventive Actions (CAPA) investigations. Own or support NC/CAPA documentation as needed.
- Communicate possible NCs or other compliance risks to the Director of Facility Engineering.
- Manage automation system changes in accordance with site change control procedures.
- Perform system assessments and propose automation projects geared to increase quality, safety, cut cost or increase production.
- Perform small to medium automation code updates associated with small to medium projects (while following the Integra Change Control procedures)
- Provide on-call emergency support as required (in the event SME assistance is needed).
- Support analysis, troubleshooting, diagnostics and repair of equipment in a prompt manner that will minimize production downtime.
- Manage automation projects and automation vendors to deliver new systems, change existing systems, or retire existing systems to support business objectives.
- Maintain system inventory information and backups of all validated software.
- Support network maintenance and projects owned by GAC/IT. Communicate and coordinate all network or system interruptions with system users.
- Set departmental objectives and goals in accordance with the plant priorities.
- Contribute to the development of plant objectives, goals and strategies.

Skills & Competencies

- Bachelor's Degree in electronics, Electrical Engineering or other related technical field with 15+ yrs of experience
- 10+ years of experience in managing engineering staff, external vendors, and activities.
- Requires solid understanding of electricity, electrical circuits, analog and digital input/output devices.
- Must be able to read and understand electrical diagrams and P&ID's.
- Knowledge of Allen-Bradley PLC programming software (RSLogix, RSLinks, FactoryTalk, and ControlLogix) required.
- Knowledge of Modicon and Siemens PLC programming software preferred.
- Prior experience in the implementation and management of similar Control/Automation systems in MedicalDevice/Pharma environment preferred.
- Knowledge of the Ethernet and BACnet Communication Protocols.
- Ability to multi-task, prioritize and work in a fast-paced environment.
- Able to work with minimal supervision.
- Available to travel on a minimal basis for training purposes.
- Familiarity with high voltage equipment operation, maintenance, and safe test procedures as required.
- Understanding of cGMP, cGDP, Computer System Validation (CSV)
- Working knowledge of Lock out Tag out (LOTO} procedures.
- Working knowledge of Facility Monitoring and Building Management Systems
- A record of safe operations and working knowledge of safety standards for plant environments.
- Proficient in Root Cause Analysis (RCA) and Failure Mode and Effects Analysis (FMEA).
- Strong writing and communication skills.
- Knowledge of personal computers and software like MS Project, Word, Excel and Power Point.
- Experience with CMMS and CMS software.
- Must be available during scheduled shutdowns, in emergency situations, and / or work flexible hours.

PHYSICAL REQUIREMENTS

The physical requirements listed below represent the motor and physical abilities necessary to successfully perform the essential duties of this position. In accordance with the Americans with Disabilities Act (ADA), reasonable accommodations may be made to enable individuals with disabilities to perform these duties.

While performing the responsibilities of this role, the employee is expected to: Sit, listen, speak, and move throughout various areas of the building. Travel across all company locations as needed. Periodically lift and/or move items up to twenty-five pounds. Travel domestically and internationally via car, train, or airplane, as required by the role.

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Salary Pay Range:

$125,350.00 - $172,500.00 USD Salary

Our salary ranges are determined by role, level, and location. Individual pay is determined by several factors including job-related skills, experience, and relevant education or training . In addition to base pay, employees may be eligible for bonus, commission, equity or other variable compensation . Your recruiter can share more about the specific salary range for your preferred location during the hiring process.

Additional Description for Pay Transparency:

Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance, and savings plan (401(k)).

Subject to the terms of their respective policies and date of hire, Employees are eligible for the following Total Rewards | Integra LifeSciences

Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.

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Unsolicited Agency Submission

Integra LifeSciences does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. A formal written agreement is required before engaging any agency, and it must be executed and authorized by the Vice President, Talent Acquisition. Where agency agreements are in place, introductions (the initial sharing of a candidate’s name, resume, or background) are position-specific and may only occur within the scope of that approved agreement. Please, no phone calls or emails.

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