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Engineer/Scientist III - Plasmids

Employer
Pfizer
Location
Andover, Massachusetts
Start date
Jun 24, 2022

View more

Discipline
Science/R&D, Biotechnology
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Genetown, Best Places to Work

Role Summary

The role will support a recently built facility that manufactures a key component of Comirnaty - Pfizer’s vaccine for Covid-19, Duchenne’s Muscular Dystrophy (DMD) gene therapy treatment, and new clinical programs. We take pride in our agility, quality, flexibility, and ability to get the job done. As examples, tech transfer start to FDA approval took under six months and we produce new Covid-19 variants right first time within days of cell bank manufacture.

The ideal candidate to join our team will share the values that have made us successful.

The incumbent will be responsible for technical support for the manufacturing process. Additional responsibilities include using operational, technical knowledge, and training to lead tech transfer, investigations, analyze process data, and identify and implement moderately complex process improvements, and troubleshooting activities.

Role Responsibilities

  • Individual will be expected to contribute to and participate in continuous improvement and innovation initiatives. Individual is expected to be or develop into an M1 coach and assist in M2/M3 opportunities.
  • Individual will provide expertise in supporting process and author product related investigations, execute CAPAs, and provide impact assessment of moderately complex process and equipment change controls to ensure a robust and capable solution with minimal supervision.
  • Individual will contribute to continuous efforts to minimize manufacturing related investigations
  • Contributing to assessment of process performance and predictive analysis with identification of course correction (if required).
  • Individual will contribute to and lead efforts to improve process yields, reduce manufacturing related costs, and minimize process variability
  • Contribute to as an operations point of contact for technology transfer and start-up of products by reviewing process parameter tables and approval of applicable documentation.
  • Generate process overview presentations, sampling plans, and other tech transfer deliverables (if required).
  • Evaluation of unit operations, executions, and changeover (long-term)
  • Troubleshooting of complex process disturbances, identifying resolution and implementing corrective and preventive measures, as required
  • Capable of managing intra-departmental projects and performing relevant presentations with minimal supervision.
  • Individual will be required to perform process monitoring, data analysis, and data preparation for presentation in several forums including project team meetings.
  • The individual will be responsible for leading within the department as well as other departments to plan, communicate, and coordinate activities.
  • Individual will be responsible for authoring and/or approving job related documentation.
  • Lead process related change controls and ensure quality of LIMS master data requests and SAP changes, as needed
  • Individual will drive the evaluation and assist in the implementation of new technology for process execution and/or analysis.
  • Individuals are responsible to ensure a safe work environment and to lead job hazard analysis and qualitative risk assessments.
  • Individuals will be required to develop the multi-tasking skills of peers.
  • Escalates and remediates with various levels of management when there is a risk to operations, personal safety, equipment functionality, product supply and/or to quality/compliance.
  • Individual should be involved in mentoring junior level scientists/engineers.
  • Support on-going GMP and inspection readiness

Qualifications

Must-Have

  • BS in Science /Engineering 4+ years
  • MS (related) 2+ years

Nice-to-Have

  • Experience in a biopharmaceutical environment is preferred ​



PHYSICAL/MENTAL REQUIREMENTS

  • Daily routine may require moving heavy equipment, standing for long periods of time, and/or walking throughout the suite including up and down stairs.
  • Must have the ability to lift ~50 pounds.
  • The incumbent needs to take the necessary safety precautions when working with pressurized systems, steam and/or corrosive chemicals.
  • The incumbent is required to attain detailed knowledge of the operational equipment.
  • The incumbent will be required to solve problems regarding site assessment, specific units used in Biopharmaceutical manufacturing.
  • The incumbent must be able to express ideas into SOPs, MBRs, MFRs and be able to use a multitude of programs including Excel, Word, Power Point, etc.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

  • Note: Shift start and end time may be staggered across a shift team to provide wider coverage across the operational day, and also may vary from those listed below.
  • 1st shift 8am – 4:30pm, Monday - Friday
  • Off-shift coverage may be required
Relocation support available

Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.

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.

Manufacturing

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