Senior Controls Engineer

Description

We are hiring a Senior Controls Engineer who is responsible for the control systems on the manufacturing and packaging equipment at the Minnesota site. This role will support the design, procurement, installation, and qualification of GMP process equipment.

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

About Us:

Our focus is on health care products that improve people’s lives. We are a market-leading generic prescription pharmaceutical company that specializes in “extended topical” medications, like creams, foams, mousses, gels, liquids and inhalable products. It’s a great time to join our team because we have a high growth trajectory with now more than 1,300 employees across six locations in the United States and Israel. We’ve already established a successful track record of launching first-to-file and first-to-market generic pharmaceutical products that have helped to make prescription products more affordable for patients and reduce costs for the healthcare system. Our team members work in a dynamic environment where opportunity is built on a foundation of honesty and transparency. Please consider joining our team where great things are happening and you can make a difference.

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