Position Summary:

ultrainnovative – Tackle rare and dynamic challenges

Engineering Management: Oversees the automation engineering team's day to day operations and metrics. Ensures that manufacturing & facilities equipment is functional and fit for its intended use. Ensures operations are supported, and that troubleshooting and process improvements are implemented with a quality mindset. The Business System Owner for the site's automation systems: the Qualified Monitoring and Alarm System (QMAS), the site Process Automation System (PAS), the Historical Data system PI, and the Building Monitoring System (BMS).

Work Model:

Core Lab & Ops: This role typically requires that the majority of the work be conducted on-site.

Responsibilities:

1. Strategic Focus Areas:

a. Development of an Automation Roadmap that encourages continuous improvement through the identification and implementation of new ideas that positively impact a segment or area of the organization and its overall performance.

b. Evaluate new technologies for their application in GMP manufacturing facility.

c. Collaboratively work with IT and other internal and external partners to resolve issues and improve site performance.

2. This job requires a level of technical proficiency in multiple skill areas and the ability to interpret complex information to solve problems. It also requires a service provider mindset that supports a variety of customers within Manufacturing, Engineering, Validation, QC, etc.

3. Works independently to drive all automation strategies and deliverables with limited to no direct supervision or technical oversight required. Represents automation systems and programs to worldwide regulatory agencies.

4. Ability to present to and solicit alignment from senior leadership on both known and unknown challenges/problems.

5. Provide technical solutions to a wide range of process, building, and networking challenges associated with automated systems.

6. Subject matter expert in all site automation systems.

7. Program, configure, and integrate equipment into the site OT Network, QMAS, and BMS systems.

8. Develop, review, and approve engineering documentation including equipment specifications, test protocols, engineering standards, and procedures.

9. Support the Manufacturing facility and QC Laboratory with regards to automation and instrumentation requirements.

10. Participate in cross functional teams created to perform investigations, root cause analysis, CAPA creation or improvement opportunities as needed.

11. Ensure that all required training is completed on time and current.

12. Manages employees and contract staff.

13. Manages contracts/SOWs, purchase orders, budgets for automation support & initiatives.

14. Establishes operational objectives and work plans and reviews objectives to determine success of the Automation Engineering department

15. Participates with other senior managers to establish plans and objectives and make decisions on operational matters

Requirements:

1. Required education: Bachelor's degree in chemical, Electrical, Mechanical, Biomedical Engineering, or Computer Science with appropriate industrial controls experience.

2. 10+ years of experience in manufacturing support environment, as a system integrator or automation engineer. 5+ years of Management experience preferred.

3. PLC and DCS coding, installation, and support, including but not limited to Allen Bradley, Siemens, and DeltaV.

4. Understanding and configuration of systems such as PI, Win-911, and InfoBatch.

5. Experience with BMS systems (Delta Controls preferred).

6. Experience with analytical equipment such as balances, pH/DO meters, Nova FLEX2, Beckman Coulter Vi-CELL, filter integrity testers, etc.

7. Understanding of instrumentation, electrical, and wiring standards.

8. Understanding of network architecture, including firewall, and switch configuration and virtualized environments.

9. Familiarity with industry standard communication protocols such as Ethernet IP, PROFINET, Modbus TCP, OPC, and BACnet.

10. Experience with current trends in automation and instrumentation to be able to select and implement modern controls architectures.

11. Adherence to domestic and international GMP regulations.

12. Experience with data integrity, specifically the understanding of FDA Part 11 and European Annex 11 requirements and experience applying these standards to the qualification of automation systems.

13. Able to effectively manage the automation lifecycle of controls components.

14. Familiarity with bioprocessing systems for Drug Substance and Drug Product manufacturing.

Physical Demand Requirements Manufacturing:

Facilities Mechanic:

• Stand for extended periods of time with periodic stooping / bending / kneeling.

• Ability to climb ladders and stairs of various heights.

• Able to lift, push, pull up to 50lbs.

• Work in a controlled environment requiring GxP gowning and wear protective clothing over the head, face, hands, feet, and body. This requires the ability to change clothes into appropriate gowning and personal protective equipment.

• Certain tasks may require use of a respirator; medical clearance will be required in advance.

• Must remove all make-up, jewelry, and contract lenses while in the manufacturing environment.

• Working in termperature-controled environments (cold rooms).

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