Manager, Engineering (Automation)

301044 Fresenius Kabi USA, LLC; North Carolina; On-site; USD 91,000 - 127,000; Full time

Benefits offered by this job

401(k) plan with company contributions

Health benefits (medical, dental, vis­

Paid vacation, holidays, personal days

Life insurance and disability

Wellness program

Job summary

Fresenius Kabi USA seeks an experienced Site Automation Manager to lead design, installation, start-up and maintenance of site systems. You will manage Automation Engineers and interns, drive cGMP compliance, and improve plant quality and efficiency.

The role oversees budgets, vendor relationships, lifecycle documentation, and cross-functional collaboration to enhance modernization and safety across manufacturing lines. Strong leadership and regulatory knowledge are essential.

Qualifications

• Bachelor's degree in engineering or related field.
• Experience leading automation teams in a regulated manufacturing setting.
• Strong knowledge of cGMP, ISO 14001, ISO 50001, and OSHA requirements.

Responsibilities

• Oversee day-to-day operations of the automation department.
• Lead, mentor and develop engineers and interns.
• Ensure robust support of engineering, manufacturing and facility operations.

Skills

Automation leadership

Team management

Regulatory compliance

cGMP knowledge

Education

Bachelor's degree in Engineering

Tools

SCADA systems

DCS

Lifecycle documentation

Job description

Job Summary

Manage, train and lead the site automation team to ensure efficient design, installation, start-up, documentation, maintenance, modification and automation of site systems. Directly manages Automation Engineers and interns to meet all regulatory and Company specific policy requirements and to improve plant quality, operational efficiency/effectiveness, capacity, capability, and modernization objectives. Salary Range: $90,816 - $126,991 Position is eligible to participate in a bonus plan with a target of 10% of the base salary. Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities. Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most. Benefits offered include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits to include medical, prescription drug, dental and vision coverage.

Responsibilities

• Oversee, manage and ensure successful day to day operations of the automation department for the site.
• Provide leadership by directing, mentoring, coaching, and developing team towards professional growth and enhanced job performance.
• Ensure robust day-to-day support of all engineering, manufacturing and facility operations
• Assist maintenance and operations in problem solving and process improvements.
• Responsible for the management of process and building controls, automation and computerized systems that adhere to current Good Manufacturing Practices (cGMP).
• Responsible for continuously improving automated processes and building controls and management of computerized systems.
• Actively lead, collaborate, and support cross-functional teams during the design and installation of new or upgraded manufacturing lines and automation systems.
• Manage equipment and system vendors, service providers and contractors
• Manage departmental and capital budgets.
• Manage the preparation and approval of Lifecycle documentation for new and upgraded equipment, facilities, and utilities.
• Maintain cGMP, OSHA, and DEC compliance through implementation and adherence to SOP’s and governmental regulations.
• Review final documentation packages for all major systems at the plant including, but not limited to utility systems, filling operations, packaging operations, steam sterilizers and process washers.
• Participate in and resolve audit and regulatory deficiencies.
• Hire, develop, organize and lead staff.
• Establish and implement appropriate engineering staff training requirements.
• Serve as reviewer and approver for deviation investigations
• Additionally responsible for Ensures department personnel are aware of the Environmental Management and Energy Management Systems and promotes continual improvement taking accountability for the effectiveness of the Environmental Management and Energy Management Systems according to ISO 14001 and ISO 50001 standards.
• Responsible for ensuring that Health, Safety and Environmental requirements are met under ISO 14001 standards.
• Responsible for ensuring that Energy Management Requirements are met under ISO 50001 standards.
• Responsible for ensuring compliance to Occupational Health and Safety is met under ISO 45001.

Additional Information

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company contribution, and wellness program. Please note that joining our team does not create a guaranteed or permanent employment arrangement. All employment is at‑will, meaning both the employee and Fresenius Kabi have the right to end the employment relationship at any time, in accordance with applicable federal and state laws. Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status. Fresenius Kabi is a global health care company that specializes in injectable medicines, biosimilars, and technologies for infusion, transfusion, and clinical nutrition. Our expansive portfolio of products and global network of science and manufacturing centers provide essential support for the care of critical and chronically ill patients. With more than 41,000 employees worldwide, our dedicated team is united by our shared purpose: to put lifesaving medicines and technologies in the hands of people who care for patients – and to find answers to the challenges they face. We call this purpose caring for life. Our U.S. headquarters is in Lake Zurich, Illinois and the company’s global headquarters is in Bad Homburg, Germany.

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