Under limited supervision and in accordance with the laws, federal regulations, and applicable state and local policies, procedures and client guidelines, this position has the following tasks and duties.
- Provide support for automation and control systems for a 24/7 operations.
- Oversee the development and revision of software and hardware requirements and design documentation.
- Perform software and hardware testing, including customer reviews, source code checks, and unit, integration, system, and platform-level tests.
- Install or coordinate installation of automation control hardware and software, including vendor engagement.
- Manage and troubleshoot control system problems, provide solutions, and implement actions.
- Provide technical support to the automation technicians in field and software interventions.
- Identify customer requirements and address concerns related to both new and existing control systems.
- Monitor, analyze, and define action plans to reduce control system situations and/or interventions.
- Perform analysis to identify trends. Understand data trends and proactively get involve and/or support discussion and action plans.
- Evaluate automation code or systems to prevent safety, environmental, or quality risks, product loss, or unplanned downtime.
- Conduct and lead investigations, while proactively assessing events to prevent interventions and eliminate recurrence.
- Initiate and implement change controls to optimize the systems or processes, including business case, technical recommendations, and resources/cost estimates.
- Develop, review and/or approve Computer System Validation (CSV) documentation.
- Prepare AQMS reports and perform audit trail evaluations.
- Follow policies and procedures to maintain the validation state of the control systems.
- Participate actively in meetings and huddle board discussions.
- Maintain process team and/or supporting areas informed of activities and status, as applicable.
- Promptly identify any roadblocks and communicate them to the relevant stakeholders in a timely manner.
- Represent the Automation area by sharing priorities, strategies, schedules, and project updates to team members.
- Be influential and vocal in the teams.
- Ability to connect how equipment, control system and process changes will affect automation and vice versa.
- Understand and actively support the delivery of key site strategic initiatives.
- Demonstrate proficiency in area control strategies and actively monitor key operational parameters within the assigned area (Quality & EHS). Ensure compliance with all relevant internal and external Computer Systems Quality policies, procedures, and regulations applicable to the supported automation systems.
- Ensure compliance with Environmental, Health and Safety regulations and internal programs.
BS Engineering (Electrical, Chemical, Computer, Mechanical, Industrial)
3-5 years of experience supporting bulk pharmaceutical operations
Requires solid DeltaV programming skills, particularly with batch processes.
- Computer systems validation experience in regulated operations (preferably GMP operations)
- Able to use a logical, systematic approach to problem solving.
- Ability to manage multiple projects and prioritize work based on business needs.
- Strong leadership and communication skills
- Learning agility
- Effective teamwork and collaboration skills
- Available to work or provide support to a 24/7 operation
*Weil Group is proud to be an Equal Employment Opportunity Employer.*