Travel: Yes, 25 % of the Time
Description:
We are hiring a Senior Controls Engineer who is responsible for the control systems on the manufacturing and packaging equipment in the Pharmaceutical/Manufacturing Industry.
Job duties:
- SME for PLC, HMI, and Robot software updates and programming.
- SME for audit trails, batch trails, and data integrity on commercial equipment.
- Responsible for creating new Robot recipes for packaging new product.
- Maintain database of software backups on all commercial equipment.
- Assist with network and LDAP authentication within the manufacturing IT network.
- Draft User Requirement Specifications (URS) for manufacturing and packaging equipment.
- Organizes and generates all relevant controls data to prepare project scopes, cost estimates, economic justifications, and capital appropriation requests, as required, to obtain management approval. Manage and maintain project budgets; ensure project execution per planned budgets.
- Create and update GMP documentation as needed by the project, including, but not limited to, equipment qualifications, change controls, SOP’s, equipment manuals.
- Troubleshoots complex equipment related issues and develops sound engineering solutions to address identified problems for assigned systems.
- Engage with both internal personnel and external vendors for issue resolution.
- Supports site reliability efforts by monitoring key equipment performance variables and proactively identifying and addressing issues before they cause unplanned equipment downtime.
- Initiate and own change controls for equipment modifications.
- Lead investigations to adequately identify root cause and implement appropriate corrective and preventative actions (CAPAs) to prevent reoccurrence.
- Routinely interact with internal Technical Services, QA, and EH&S personnel to achieve project and production goals.
- Lead for the execution of start-up and commissioning activities for minor and major equipment upgrades.
- Contributing to equipment safety reviews.
- Champion the use of continuous improvement.
- Mentors and trains other engineers on automation practices.
- Domestic and International travel required.
- Perform other Tasks as assigned.
Required qualifications:
- Bachelor’s degree in Engineering or related field.
- 6 or more years (6+) of relevant work experience in a pharmaceutical or similar manufacturing engineering environment
- Experience with the procurement, installation, and validation of complex equipment
- Knowledge of pharmaceutical GMPs and regulatory (FDA, DEA, OSHA) requirements
- Strong written and oral communication skills, technical writing experience
- Excellent interpersonal skills, with the ability to work independently and prioritize critical tasks
- Proficient in Microsoft Office, and some or all of: CAD software, ladder logic programming, Rockwell Automation software/hardware, Siemens software/hardware, Fanuc Robots, Universal Robots, and ABB Robots.