Associate Director - Automation Engineer & Metrology

POSITION SUMMARY:

The Associate Director of Automation Engineer is responsible for specifying, selection, configuration, planning, procurement, programming, troubleshooting, installation and commissioning of process, materials handling and utilities software and electrical controls for Programmable Logic Controllers (PLC), Human Machine Interfaces (HMI) and Supervisory Control and Data Acquisition (SCADA).

The position of Lead Automation and Metrology Department for routine automation projects, automation based breakdown, Schedule and on-demand calibration handling through In-house and outside vendor.

The key role is for regulatory compliance in Automation, Part 11 compliance, CSVMP validation and Metrology as per relevant guidelines.

OVERALL JOB RESPONSIBILITIES

Responsibilities

Lead Automation & Metrology area

Lead Automation and Metrology department under key responsibility of on-site and outside calibration and Automation project.

• Automation & Maintenance solution to minimize equipment downtime and optimize the performance.
• Prioritize and understand scope, schedule management skills for automation controls projects, metrology, engaging operations personnel from Maintenance to site leadership
• Complete all required training as per training schedule and make sure your team will complete the training too.
• Troubleshoot automation related issues related to HMI, PLCs, SCADA, VFDs, Servo drive, Network communications, BMS, EMS, Servers, Robotics and instrumentation sensor but not limited to and provide training for Maintenance staff to troubleshoot automation and controls issues. Strive for minimum downtime due to automation and controls issues.
• Assessment of Existing Equipment for upgradation and compliance point of view.
• Develop and execute a plan for correcting various automation and control problems that arise at the site on existing systems. Assist Maintenance staff in troubleshooting automation and controls problems that arise as needed.
• Responsible to follow for Automation and Instrumentation current SOP at the site.

Developing budgets for facility, calibration, capital projects, Automation project & improvements.

Ensuring all budgets are met, delivery of all capital initiatives.

Monroe Plant Capex as per aligned timelines - (Automation Project, Change room and other project, Metrology Budget)

• Monroe plant- Capital Cash Flow
• Budget administration

Regulatory Compliance : Drive compliance culture in impact area

Quality & Product Regulatory Audits- Compliance to cGMP standards- Timely completion of Inspection remediation work and response.

Site Quality targets - SOP, CAPA, and Issue & CC timely completion.

• Completion of all Training on time
• Support and active participant in various regulatory inspection, audit and compliance.

EHS Compliance : Drive compliance culture in impact area

EHS Statutory Compliance - Ensure compliance to Statutory Compliance Improvement Program.

EHS Standards Compliance - Near Miss

Ensure EHS procedures & practices are followed to have Zero loss time accidents & zero non compliances

Deliver Site Specific Project (Automation upgrades, Existing machine upgrades, Part 11 Compliance project & Primary change room project)

(Interact with cross-functional teams, contractors, and stakeholders to ensure proper reviews and requirements are met)

Ensuring the proper design reviews are performed for all logic control sequences and automation design projects including documentation like control user requirement specifications, functional requirement specifications, and design qualification documents for new equipment and/or projects

• Automation & Maintenance solution to minimize equipment downtime and optimize the performance.
• Project completion and time.
• Develop and execute a plan for correcting various automation and control problems that arise at the site on existing systems
• Ability to cope with rapidly changing priorities based on current business needs.
• Create general arrangement plan view mechanical drawings for integration of new equipment in to existing production lines.
• Market research & Identification of suitable suppliers/Integrator/Software vendors.
• Maintain and develop performance measurements to identify areas for improvement.
• Work with the various disciplines at the site to coordinate execution of automation validation, commissioning, and turnover of automation projects
• Develop and manage the software programming, platforms, and standards to integrate the site process systems for specific applications.
• Participate in site/factory acceptance testing as it relates to automation and controls.

KNOWLEDGE, SKILLS AND ABILITIES

Education

Minimum Bachelor’s degree in Electrical, Computer Science, Chemical Engineering with minimum 10-12 years automation or controls and experience.

Experience

10-12 years in a similar technical role.

• Experience in managing automation projects and commissioning activities.
• Strong understanding of PLC/HMI/SCADA platforms and programming skills (i.e., Rockwell Studio 5000, FactoryTalkView ME/SE, and TIA Portal).
• Experience with other platforms helpful (i.e., FT Batch, FT Pharma Suite, FT Production Centre, PlantPAX, PI-Historian, iFix, Ignition, Wonder ware, and etc.).
• Experience in leading the project teams and contractors.
• General understanding of cGMP, 21 CFR Part11, ERES, and data integrity.
• Real time data collection and storage from processes to enterprise level databases, future need (Factory Talk Transaction Manager, Factory Talk Historian, Factory Talk Asset Centre, Factory Talk Batch, SQL server databases, stored procedures and SQL coding).

Knowledge and Skills (Functional / Technical)

• Knowledge and relevant training of FDA compliance, EU, global GMPs including Good Automated Manufacturing Practices (GAMP 5), EU cGMP Annex 11, and 21CFR Part 11.
• Software development in Real-Time data in automated system and process control applications.
• Self-starter, goal driven, highly technical, keen to compliance and safety.
• Experience managing automation projects and commissioning activities with production.
• Experience managing vendors for automation project installation and commissioning.
• Experience reverse engineering and debugging of automation systems with limited documentation.
• MS Project and MS Office applications.

Leadership / Managerial Attributes

• Lead Automation and Metrology department under key responsibility of on-site and outside calibration and Automation project.
• Demonstrates a hands-on, energetic, accountable and hardworking leadership style.
• Prioritize and understand scope, schedule management skills for automation controls projects, metrology, engaging operations personnel from Maintenance to site leadership.
• Ability to integrate critical information and champion strategies/concepts through the organization and drive development of advanced technologies, principles and processes.
• Thinks broadly and resolve complex automation related issues with the good judgement, knowledge, and experience.

Adept at performing in a high paced environment, be flexible to business/management needs, and resourceful.

• Training certificates from Rockwell Automation platform: PLC/HMI/SCADA.
• Additional training certificates: AVEVA Wonder ware, robotics, and vision systems are desired.
• Commissioning and CSV experience in pharma are plus.