Job Summary
POSITION 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.
Responsibilities
PRINCIPAL ACTIVITIES PERFORMED BY THE INCUMBENT
- 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.
REQUIREMENTS
- BS in an Engineering, Science or related technical discipline required
- Minimum 5 years of experience in an engineering and/or manufacturing setting, cGMP / Pharmaceutical environment preferred
- Knowledge of all aspects of manufacturing processes, automation and controls including PLCs and HMIs, SCADA, data historians, manufacturing execution systems, machine design and layout
- Experience with advanced analytics, machine learning, vision systems or robotics are a plus
- Analytical skills in problem solving
- Must be proactive, have experience with high performance teams, strong interpersonal and project management skills
- Must have good technical written and verbal communication skills, good documentation skills, good organizational skills and good interpersonal skills to collaborate with the plant staff.
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, andwellness program. 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.
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