Senior Specialist, Engineering - External Manufacturing Vaccine Technical Operations
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Job Description
Position Description:
The External Manufacturing Vaccine Drug Product Technical Operations (ExM Vaccine DP TO) organization is seeking a highly motivated individual for a Sr. Specialist Engineering position. ExM Vaccine DP TO is accountable for technology transfers and commercial production of sterile drug product at our Company’s External Partners (EPs). This person will have the opportunity to participate and lead activities in all these areas.
Responsibilities include:
Work with External Partners to achieve business goals and to establish a common culture that benefits both our company, External Partners, and patients
Responsible for technical activities for the commercial manufacturing process at the External Partner, which includes authorship of change control, management of process improvement projects, statistical analysis of process performance, and investigation of atypical events
Responsible for technical transfer activities, as applicable, through authorship and/or review of required GMP documentation (Master Batch Records, change control, protocols, reports, qualifications, etc.) and regulatory filings.
Provide on-site coverage at External Partner in support of Commercial and / or Tech Transfer Person In Plant Activities
Translate understanding of GMP requirements and current regulations and develop standardized work to meet these requirements by partnering with Operations, Quality, and External Partners
Ensure that External Partners are inspection ready for all routine inspections and / or inspections related to new product introductions or transfers, in concert with Operations, Quality, and Regulatory
Responsible for participation in creating, sharing, and adopting best practices and business process strategies
Position Qualifications:
Education Minimum Requirement:
Bachelor’s degree in chemical/Biochemical Engineering, Pharmaceutical Science, or Chemistry/Biology, or other related science or engineering field.
Required Experience and Skills:
Minimum of 4 years post-bachelor's degree experience in a GMP functional area or support of a GMP functional area, such as Operations, Technical Operations, Technology, Engineering, and/or Maintenance
Travel will be a requirement of this position at up to 50%
Strong communication and teamwork skills
Preferred Experience and Skills:
Experience in sterile / aseptic manufacturing
Demonstrated ability to independently manage projects/work to schedule/deadlines
Statistics experience
Experience in deviation management and/or change control and/or equipment support, and/or project management.
Current Employees apply HERE
Current Contingent Workers apply HERE
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:
We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives,
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