Electronic Batch Record Support - Clinical Manufacturing

Employer
Pfizer
Location
Chapel Hill, North Carolina
Posted
Jul 30, 2021
Ref
4820079
Required Education
High School or equivalent
Position Type
Full time

Role Summary

Bioprocess Research & Development (BRD) Electronic Batch Record (EBR) Support Role will enable deployment, support, and continuous improvement of the EBR system in the BRD manufacturing network. They will use their technical knowledge to deploy the system at each site by assisting in the creation of new EBRs and training manufacturing colleagues. This will require communication with the EBR vendor and Pfizer digital teams to troubleshoot and communicate issues as needed. Additionally, they will provide hands-on support and will work on continuous improvement of the system when new enhancements are deployed. This work will require technical understanding of the EBR system, the needs of the manufacturing organization, and a high-level understanding of bioprocessing.

 

This position will also work closely with the BRD Digital Team and Pfizer Digital to develop and deploy EBR system enhancements and integrations with enterprise systems. These efforts will require close collaboration with digital SMEs and a sound understanding of the end-user requirements in the manufacturing network. The role will be responsible for developing project plans for new EBR initiatives and will act as the single point of contact for EBRs in the BRD network.

Responsibilities

  • Applies technical knowledge to support implementation of Electronic Batch Records (EBRs) across BRD’s GMP manufacturing network, including sites located in St. Louis, MO, Andover, MA, and Durham, NC.

  • Provides continued specialized technical support for the creation and maintenance of EBRs across the manufacturing network.

  • Trains manufacturing colleagues on EBR system during site implementation and during deployment of EBR system enhancements.

  • Works with cross-functional digital teams (Research & Development, GMP Manufacturing, I.T.) to develop and deploy both system enhancements and integrations with proprietary information systems

  • Acts as the single point of contact for GMP EBRs in BRD to provide updates on project milestones and timelines for various EBR projects.

  • In collaboration with technical experts and line leads, analyzes manufacturing needs to assist with recommendation of appropriate technical solutions and applications. 

  • Clearly understands and maintains end user requirements to enable continuous improvement of EBR system

QualificationsMust-Have
  • B.S./Associates Degree or HS Diploma, with 2-3+ years of relevant experience in information technology systems and/or a combination of experience in technology and development, production or scientific operations of biological therapeutics.

  • Previous understanding and experience working with various aspects of GMP Manufacturing.

  • Excellent computer skills with MS Office, especially Excel and Powerpoint.

  • Excellent written and oral communication skills, and interpersonal skills to effectively communicate at multiple levels in the organization. 

  • Skilled at identifying problems and attention to detail.

  • Ability to prioritize and manage multiple activities and objectives simultaneously.

  • Ability to work independently on individual goals and contribute collaboratively to team goals; enjoys achieving goals through collaborative effort.

  • Ability to work within a team, leveraging and/or engaging others to accomplish projects, and equally as an individual contributor in a fast-paced, changing environment. 

Nice-to-Have
  • Additional education/certifications in electronic batch record systems, end user application support, developing and delivering end user application training and Proficiency in Microsoft applications.

  • Proven analytical skills, problem-solving capabilities

  • Strong business and technical aptitude with an attitude to solve complex problems.

  • Ability to support large, departmental projects in a global organization.

  

Sunshine Act

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations.  These laws and regulations require Pfizer to provide government agencies with information such as a health care provider’s name, address and the type of payments or other value received, generally for public disclosure.  Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act.  Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government.  If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

EEO & Employment Eligibility

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.  Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.  Pfizer is an E-Verify employer.

Research and Development

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