Sr. Spclst , Manufacturing Automation

Job Description

Our company is expanding its global recombinant human papillomavirus (HPV) vaccine production network by investing $650 million and have added a 225,000-square-foot building within the footprint of the Maurice R. Hilleman Center for Vaccine Manufacturing in Durham, NC. The new facility is being used to produce the bulk active ingredient for the HPV vaccine, comprised of fermentation, microfiltration/ultrafiltration, and chromatography steps.

Approximately 614,000 people are diagnosed with certain HPV-related cancers each year. Our company manufactures the two HPV vaccines that are predominantly utilized to eradicate these cancers globally.  In recent years, countries around the world have enacted new or expanded HPV vaccination programs, which has created an unprecedented increase in global demand. The manufacturing facility in Durham will play a critical role in the network of plants that produce life-saving medicines and vaccines, including our HPV vaccines.

This Individual will provide leadership as the automation engineer for HPV Vaccine Facility directly supporting Alum production.  Responsible for problem resolution, implementation of process control, data collection techniques, and troubleshooting in compliance with SDLC, GMP, safety, and environmental regulations.  Actively support, participate and embrace an empowered team culture including significant interaction with manufacturing, quality and engineering groups.   Supports a large spectrum of sophisticated automated systems within Manufacturing Operations; providing multiple opportunities to learn new automation technologies and make a positive impact.  Provides direct support to Automation Lead including leading cross functional teams and providing direct guidance to the Automation team. Also provides technical coverage on automated systems.

Primary Activities include, but are not limited to:

• Understands and supports all Good Manufacturing Practices (GMPs), safety, and environmental regulations.  Review and approve automation documents, preventive maintenance, and SOPs to ensure compliance with Good Manufacturing Practices and safety.

• Leads investigations of automation incidents and problems to prevent recurrence including the development and implementation of corrective actions.

• Evaluates automated and information technology systems, and develops strategies to optimize and ensure quality and stability of automation systems through future expansion, replacement, or upgrade.

• Assists in the Automation Lead in the training, development, motivation, and assignments for employees and contractors.

• Coordinates projects with staff group for timely implementation.

• Uses technical knowledge to assure the efficient operation of variety of automated processing and information technology systems.  Leads in installing and placing new equipment into operations.  Develops solutions for automation problems.

• Participates in audits and training programs in the area of responsibility.

• Project coordination leadership and implementation of troubleshooting activities and change control.

• Initiate and lead collaboration within the Operations, Quality and Technical organizations to resolve complex problems.

• On-floor support of manufacturing activities.

• Identify and implement process/equipment improvements and manufacturing efficiencies.

• Serves as liaison with corporate and divisional automation and IT groups.

Education Minimum Requirement:

• High School Diploma or equivalent; or greater

Required Experience and Skills:

• Minimum 7 years of experience in process automation or equivalent Or 5 years with BS degree

• Experience programming Emerson DeltaV version 12+ required including Batch control

• Minimum of 4 years of GMP Computer validation and systems life-cycle development methodology experience required.

• Proven track record of analytical skills, problem solving and attention to detail

• Strong data integrity acumen

• Strong understanding of manufacturing principles/ processes and ability to translate manufacturing and business requirements into Automation/digital solution

Preferred Experience and Skills:

• BS degree preferably in Engineering, Science, or Information Technology

• Experience in the foll