Tech, Operations
Tech, Operations
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1 Vacancy
Job Description
Job Description
Technician Operations
Position Overview:
The Operations Technician will be a member of the Maintenance & Operations team within the Vaccines integrated process team for a start-up vaccine manufacturing facility in Wilson NC. This person is accountable for providing shop floor operations and environmental monitoring support to aseptic manufacturing within the vaccine manufacturing facility. Tasks will include aseptic primary filling inspection packaging and CIP/SIP. This position will also perform various roles to include executing routine room and equipment disinfection as well as managing the movement of gowning disinfectants and materials. In addition to supporting operations activities the role will be accountable for ensuring that EHS and GMP compliance is maintained within their area of position will be an individual contributor and member of the Operations team.
Delivery
Execute manufacturing operations environmental monitoring and facility disinfection
Set up and operate vaccines formulation aseptic primary filling inspection packaging CIP/SIP and additional equipment within qualified parameters
Identify potential equipment problems and partner with Vaccines Maintenance Technicians to ensure appropriate resolution. Demonstrate ability to troubleshoot process electronic systems and equipment for routine and basic problems.
Perform other duties as requested by the Operations coach
Compliance
Accountable for performing work in a safe manner following identified safety procedures (hazardous work permitting LOTO HECPs) and using applicable safety equipment / personnel protective equipment (PPE)
Execute operations functions in accordance with current Good Manufacturing Practices (cGMPs) and standard operating procedures (SOPs)
Complete documentation in batch records electronic logs or other systems in accordance with site procedure
Maintain good housekeeping and 5S in assigned work area
Adhere to the highest level of data integrity while performing duties
Identify potential quality or safety issues. Escalate as per IPT management processes and assist in the investigation root cause determination and CAPA implementation.
Cost
Ensure that startup activities for area of assignment are executed such that project deliverables and timelines are met
Closely monitor team / process performance and improve reliability through problem solving and continuous improvement
Set up and operate equipment in alignment with established training and procedures to ensure reliable operation with minimal delays or discards
Identify and help implement continuous improvement and productivity enhancements within the IPT
Team
Partner with Technicians and cross-functional groups for assigned area
Demonstrate a high degree of maturity and personal integrity. Strictly adhere to all site policies on personal conduct and attendance.
Train develop and mentor other team members to share experience and best practices
Pursue knowledge and skills in assigned area from an operations perspective and share that information readily with team
Maintain a culture of continuous improvement / MPS focused on standard work making problems visible minimizing waste reducing process variability and problem solving
Routinely demonstrates leadership and conflict-resolution ability. Demonstrates a willingness to provide and receive constructive feedback in 360 performance review.
Reporting Relationships:
Solid line report to: Manager Maintenance & Operations
Dotted line report to: N/A
Position(s) reporting to this position: N/A (individual contributor)
Work Schedule:
8-hours 2nd shift
Minimum Education Requirement:
High School diploma or equivalent
Required Experience and Skills:
Three or more years of experience in a GMP manufacturing facility (aseptic GMP environment strongly preferred).
Demonstrated ability to work independently and as team member
Demonstrated interpersonal skills with ability to influence and assist others through a culture of inclusion feedback and empowerment
Ability to gown and work in an aseptic environment
Demonstrated ability to work with computerized and automated systems.
Willing to work irregular hours to support multi-shift operation on an as needed basis
Preferred Education Experience and Skills:
Associates degree in Business Science or Technology-based field and/or bio-pharma focused certificates such as Bioworks preferred.
Experience with aseptic filling visual inspection systems CIP/SIP systems packaging equipment and similar aseptic formulation and filling operations
Experience operating maintaining troubleshooting and/or repairing industrial equipment
Experience working in a regulated environment (FDA etc.) and basic knowledge of cGMPs as they apply to the vaccine/pharmaceutical industry
Experience in Continuous Improvement Lean Manufacturing Problem Solving and/or Right First-Time methodologies
SAP / MES / electronic logbook basic knowledge from a production execution perspective
Demonstrated leadership ability peer training experience and/or productivity improvement activities
Demonstrated ability and drive to work autonomously and help organize priorities and work with other team members
Outstanding communication skills both within direct team and across multiple shifts to ensure success of overall team
Ability to support technical writing of documents such as standard operating procedures (SOPs)
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Employee Status:
RegularRelocation:
No relocationVISA Sponsorship:
NoTravel Requirements:
No Travel RequiredFlexible Work Arrangements:
Not ApplicableShift:
2nd - EveningValid Driving License:
NoHazardous Material(s):
N/aRequired Skills:
Analytical Problem Solving Analytical Problem Solving Batch Record Review Biological Manufacturing Cleanroom Gowning Computer Literacy Data Integrity Environmental Monitoring Equipment Maintenance Global Manufacturing GMP Compliance GMP Operations Good Manufacturing Practices (GMP) Healthcare Innovation Industrial Maintenance Laboratory Processes Lean Manufacturing Lean Product Development Machinery Operation Machine Troubleshooting Maintenance Processes Manufacturing Quality Control Operations Support Packaging Operations Pharmaceutical Manufacturing 5 morePreferred Skills:
Job Posting End Date:
06/19/2025*A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Employment Type
Full-Time
