Position Description, Functions, Duties and Tasks
Subject Matter Expertise & Technical Leadership: Serve as a recognized Subject Matter Expert (SME) for assigned packaging lines and processes. Utilize advanced technical knowledge to resolve complex equipment and process issues, driving root cause analysis investigations for quality events and equipment-related issues.
Operations & Maintenance: Expertly operate, maintain, install, and complete all required documentation for equipment in compliance with cGMP. Perform and often lead preventive, predictive, and complex corrective maintenance.
Advanced Troubleshooting: Analyze complex electrical, instrument, mechanical, and operational problems, developing and implementing comprehensive corrective action plans. Familiarity with Allen Bradley and Siemens S5/S7 PLC and HMI operational experience for advanced troubleshooting and process optimization.
Continuous Improvement & Projects: Champion the planning, design, and implementation of technical projects related to new packaging equipment and process optimization (e.g., productivity, throughput, cost reduction). Lead the implementation of new technology and applications of existing technology.
Documentation & Compliance: Ensure all processing, cGMP, and ES&H documentation is meticulously accurate and legible, including batch records and maintenance logs. Develop and revise Standard Operating Procedures (SOPs) and training modules for all levels of personnel, including contract staff. Ensure the Augusta Change is accurately followed and often serves as the change owner or assessor.
Team Leadership & Training: Provide leadership and coaching to others, including acting in a line leader role and mentoring Packaging Specialists and Packaging Operators. Foster a team-based environment, actively participating in team activities and providing constructive coaching.
Cross-Functional Collaboration: Collaborate effectively with Quality Assurance, Engineering, R&D, and other cross-functional teams to integrate packaging solutions and ensure alignment with business and regulatory objectives.
Minimum Qualification (Education, Experience and/or Training, Required Certifications) Education
Minimum: High School Diploma or GED and Electrical/Mechanical Certification
Preferred: Electrical/Mechanical Degree or Bachelor of Science in Packaging Science, Engineering, or related technical field
Experience: Minimum of 5+ years of relevant experience in chemical, pharmaceutical, or related process operations with a strong I/E (Instrumentation/Electrical), mechanical, or electrical background.
Demonstrated experience with process validation and qualification practices for complex systems in a regulated (cGMP) environment.
Proven ability to lead complex technical projects and cross-functional teams.
Special Skills
Advanced knowledge and ability in mechanical and electrical systems (e.g., pneumatics, sensors, motors, PLC/HMI programming, robotics, gearboxes).
Expert proficiency in using Microsoft Word, Excel, Outlook, and PowerPoint.
Strong analytical and data-driven problem-solving skills, including experience with statistical techniques for data analysis.
Excellent technical communication and writing skills for authoring complex SOPs, protocols, and technical reports.
Demonstrated project management expertise.
Qualification to perform required job tasks in packaging area.
Additional Preferences
High level of initiative and independent judgment.
Demonstrated ability to function as an SME and lead technical discussions.
Strong customer focus (internal and external) and ability to manage multiple priorities.
Team oriented.
Physical Demand Requirements
Ability to work 12-hour rotating shifts.
Must be able to perform and review work in a manufacturing plant environment.
Ability to climb stairs and ladders when required.
Physical ability to lift 40 lb. loads.
What do we offer?
Competitive Salary
Competitive Benefits Package and Employee Assistance Program
401(k) Plan + Company Match
Vacation + End of Year Vacation (Company Sponsored)
Growth Opportunities to expand your career
#J-18808-Ljbffr
Subject Matter Expertise & Technical Leadership: Serve as a recognized Subject Matter Expert (SME) for assigned packaging lines and processes. Utilize advanced technical knowledge to resolve complex equipment and process issues, driving root cause analysis investigations for quality events and equipment-related issues.
Operations & Maintenance: Expertly operate, maintain, install, and complete all required documentation for equipment in compliance with cGMP. Perform and often lead preventive, predictive, and complex corrective maintenance.
Advanced Troubleshooting: Analyze complex electrical, instrument, mechanical, and operational problems, developing and implementing comprehensive corrective action plans. Familiarity with Allen Bradley and Siemens S5/S7 PLC and HMI operational experience for advanced troubleshooting and process optimization.
Continuous Improvement & Projects: Champion the planning, design, and implementation of technical projects related to new packaging equipment and process optimization (e.g., productivity, throughput, cost reduction). Lead the implementation of new technology and applications of existing technology.
Documentation & Compliance: Ensure all processing, cGMP, and ES&H documentation is meticulously accurate and legible, including batch records and maintenance logs. Develop and revise Standard Operating Procedures (SOPs) and training modules for all levels of personnel, including contract staff. Ensure the Augusta Change is accurately followed and often serves as the change owner or assessor.
Team Leadership & Training: Provide leadership and coaching to others, including acting in a line leader role and mentoring Packaging Specialists and Packaging Operators. Foster a team-based environment, actively participating in team activities and providing constructive coaching.
Cross-Functional Collaboration: Collaborate effectively with Quality Assurance, Engineering, R&D, and other cross-functional teams to integrate packaging solutions and ensure alignment with business and regulatory objectives.
Minimum Qualification (Education, Experience and/or Training, Required Certifications) Education
Minimum: High School Diploma or GED and Electrical/Mechanical Certification
Preferred: Electrical/Mechanical Degree or Bachelor of Science in Packaging Science, Engineering, or related technical field
Experience: Minimum of 5+ years of relevant experience in chemical, pharmaceutical, or related process operations with a strong I/E (Instrumentation/Electrical), mechanical, or electrical background.
Demonstrated experience with process validation and qualification practices for complex systems in a regulated (cGMP) environment.
Proven ability to lead complex technical projects and cross-functional teams.
Special Skills
Advanced knowledge and ability in mechanical and electrical systems (e.g., pneumatics, sensors, motors, PLC/HMI programming, robotics, gearboxes).
Expert proficiency in using Microsoft Word, Excel, Outlook, and PowerPoint.
Strong analytical and data-driven problem-solving skills, including experience with statistical techniques for data analysis.
Excellent technical communication and writing skills for authoring complex SOPs, protocols, and technical reports.
Demonstrated project management expertise.
Qualification to perform required job tasks in packaging area.
Additional Preferences
High level of initiative and independent judgment.
Demonstrated ability to function as an SME and lead technical discussions.
Strong customer focus (internal and external) and ability to manage multiple priorities.
Team oriented.
Physical Demand Requirements
Ability to work 12-hour rotating shifts.
Must be able to perform and review work in a manufacturing plant environment.
Ability to climb stairs and ladders when required.
Physical ability to lift 40 lb. loads.
What do we offer?
Competitive Salary
Competitive Benefits Package and Employee Assistance Program
401(k) Plan + Company Match
Vacation + End of Year Vacation (Company Sponsored)
Growth Opportunities to expand your career
#J-18808-Ljbffr