HPV Operations Training Specialist

Job Description

Our Manufacturing Operations teams are the people that make our products. We work in the manufacturing plants with a “Safety First, Quality Always” mindset striving for continuous improvement. We work in the local plant connected to our global manufacturing network to ensure the highest quality of raw materials, intermediates and finished products.

The Maurice R. Hilleman Center for Vaccine Manufacturing is located in Durham, NC. Due to the importance of this facility in our Company Vaccine Manufacturing network, the facility has seen rapid growth in production volumes and new employees over the last several years; currently Durham employs 1,000+ people.

This role as a Training Operations Specialist will be an energetic individual with strong interpersonal, leadership, and collaboration skills responsible for supporting Operational Readiness projects and initiatives for a new manufacturing facility. This role will contribute to the overall performance and results of a E2E drug substance department.

Responsibilities may include but are not limited to;

• Partnering with the Operations management team to create and execute strategies that support design, development, delivery and evaluation of projects related to steady-state production and/or continual process improvement.

• Authoring and reviewing documents and SOPs.

• Author deviations and works to coordinate, develop and implement Corrective Actions/Preventive Actions (CAPAs).

• Ensuring visibility and accuracy of the project schedule and update dashboards accordingly to highlight the project status of critical milestones.

• Ability to effectively support, upskill and mentor new employees

• Analyzing and implementing initiatives that will help to increase overall success within the department.

• Effectively using metrics and measurement to ensure that projects and initiatives result in desired outcomes.

• Ability to prioritize workload under guidance from management.

Education Minimum Requirement:

• High School Diploma AND at least Five (5) years in a manufacturing, technical, support, or Military role. OR

• Bachelor’s degree in a technical field AND at least Three (3) years in a manufacturing, technical, support, or Military role.

• Bachelor's degree and at least two (2) year of experience in a direct GMP, biotechnology, manufacturing setting.

Required Experience and Skills:

• Experience working in a GMP environment

• Demonstrated written and verbal communications skills

• Ability to foster a collaborative work environment

• Demonstrated interpersonal, technical aptitude, and problem-solving skills

• Strong team skills, including the ability to coach/develop work teams, provide training, motivate/empower others, and resolve conflict

• Must be flexible and able to manage multiple priorities

Preferred Experience and Skills:

• Experience and comfortability delivering training in a group environment

• Understanding of Lean Six-Sigma methodologies

• Experience with shop-floor cGMP manufacturing and related systems (i.e. SAP)

• Familiarity with pharmaceutical regulatory requirements

• Project management and data analysis skills

• Technical writing experience

• Experience with facility, equipment and/or process start up activities in a cGMP environment

• Demonstrated ability to work independently

• Production planning / scheduling experience

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor. VETJOBS #EBRG

Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or rese