Associate Technician, Operations

NCBiotech; Wilson (NC); On-site; USD 43,000 - 68,000; Full time

Benefits offered by this job

Medical, dental, vision insurance

401(k) retirement plan

Paid holidays and vacation

Sick days

Job summary

NCBiotech is seeking a Bio Process Operations Technician (2nd shift) in Wilson, NC to support aseptic vaccine manufacturing on the Maintenance & Operations team. You will perform aseptic filling, inspection, packaging, CIP/SIP and manage gowning, disinfectants, and materials with compliance to cGMP and safety policies.

Responsibilities include executing operations, documenting in electronic batch records, assisting with troubleshooting, and participating in continuous improvement.

Qualifications

• 0–1+ years in a GMP manufacturing facility (aseptic GMP environment preferred).
• Ability to gown and work in an aseptic environment.
• Demonstrated ability to work independently and as a team member.

Responsibilities

• Execute manufacturing operations and facility disinfection.
• Set up aseptic vaccine manufacturing including primary filling, inspection, packaging, CIP/SIP.
• Document in electronic batch records and follow SOPs.
• Maintain 5S and data integrity.

Skills

GMP compliance

Data integrity

Teamwork

Communication

Ability to gown in aseptic environment

Education

High School diploma

Tools

SAP

MES

Electronic logbook

Job description

Job Description

Bio Process Operations Technician (2nd shift)

The Bio Process 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 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 assignment. This position will be an individual contributor and member of the Operations team.

Delivery

• Execute manufacturing operations and facility disinfection
• Set up and perform aseptic vaccine manufacturing to include 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 electronic batch records, electronic logs, and 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 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 2:00PM-10:30PM

Minimum Education Requirement

High School diploma or equivalent

Required Experience and Skills

• 0-1 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)
• Job Description In Secondary Posting Language(s) (Include Requirements For Education, Experience And Skills)

Required Skills

Chemical Plant Operations, Chemical Plant Operations, Computer Literacy, Continuous Process Improvement, Data Integrity, Environmental Controls, GMP Compliance, Good Manufacturing Practices (GMP), Industrial Machinery Repair, Job Descriptions, Lean Manufacturing, Maintenance Processes, Manufacturing Operations, Operations Support, Packaging Equipment, Pharmaceutical Production, Pharmaceutical Quality Assurance, Production Execution, Production Scheduling, Safety, Health, Environment and Quality (SHEQ), Safety Procedures, Shift Work, Shop Floor Management, Standard Operating Procedure (SOP), TB Screening {+ 2 more}

Preferred Skills

We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days.

The salary range for this role is:

$43,100 - $67,800

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

US and Puerto Rico Residents Only

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement

We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

San Francisco Residents Only

We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only

We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

Employee Status

Regular

Relocation

No relocation

VISA Sponsorship

No

Travel Requirements

No Travel Required

Flexible Work Arrangements

Not Applicable

Shift

2nd - Evening

Valid Driving License

No

Hazardous Material(s)

na