01 Jun, 2021

Process Engineer

  • Pfizer
  • Andover, MA, USA
Process Engineer Biochemicals / Pharmaceuticals

Job Description

Why Patients Need You

 

Our breakthroughs would not make it to the hands of patients without our pharmaceutical manufacturing team. We rely on a team of dedicated and agile members, who understand the importance and impact of their role in Pfizer’s mission. Patients need colleagues like you who take pride in their work and always look to improve outcomes. You will help to ensure that patients and physicians have the medicines they need, when they need them.

 

What You Will Achieve

 

You will be accountable for activities involved in the production of drug substance or active biological ingredients (ABI). You will assist in leaded the production staff to achieve targets, and deliver and improve process or product consistency, quality/compliance, and customer service. Due to your expertise in the manufacturing domain, you will participate in training for operational qualifications and assist the Team Lead or other team members as needed. You will conduct all activities in accordance with Company policies and standard operating procedures, Pfizer Values, and global regulatory guidelines, environmental guidelines etc.

 

As a senior associate, your focus on the job will contribute in achieving project tasks and goals. Through your comprehensive knowledge of principles, concepts and theories of the discipline, you will also work towards advancing new concepts and methodologies.

 

It is your hard work and focus that will make Pfizer ready to achieve new milestones and help patients across the globe.

 

ROLE SUMMARY

 

The engineer/scientist in manufacturing operations is responsible for execution of the manufacturing process in a multi-product cGMP facility capable of manufacturing commercial, clinical and development drug substance. Additional roles include using operational and technical knowledge to lead troubleshooting activities, tech transfer and start-up activities, investigations, analyze process data, and identify and implement moderately complex process improvements.
 

ROLE RESPONSIBILITIES

  • Leading relevant process activities including protein purification or cell culture operations (depending on the background of the candidate), solution formulation, and equipment preparation (set-up, CIP, SIP) by following established SOP’s.

  • Leading the setup and evaluation of unit operations, executions, and changeover (daily and long-term)

  • Troubleshooting of complex process disturbances, identifying resolution and implementing corrective and preventive measures, as require

  • Real time assessment of process performance and predictive analysis with identification of course correction (if required). 

  • Individual will be required to perform process monitoring, data analysis, and data preparation for presentation in several forums including project team meetings.

  • Serve as the 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).  

  •  Capable of managing intra-departmental projects and performing relevant presentations with minimal supervision. 

  • Individual will provide subject matter expertise in supporting process and author product related investigations, execute CAPAs, and provide impact assessment of complex process and equipment change controls to ensure a robust and capable solution with minimal supervision.

  • Individual will help to ensure the equipment and facilities are maintained in a GMP compliant state at all times.

  • The individual will be responsible for leading within the department as well as other departments to plan, communicate, and coordinate activities.

  • Individual will assist in leading the inventorying, tracking, maintenance scheduling, and troubleshooting of mechanical equipment.

  • Individual will be responsible for authoring and/or approving job related documentation.  

  • Individual will drive the evaluation and assist in the implementation of new technology for process execution and/or analysis.

  • Individual will be expected to participate and drive in continuous improvement and innovation initiatives.  Individual is expected to be an M1 coach. 

  • 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

 

Qualifications

 

Must-Have

  • 4+ Bachelor's Degree

  • Experience within the pharmaceutical industry

  • Effective verbal and written communication skills

  • Mechanical knowledge and the use of hand tools

  • Demonstrated ability to train and coach others

  • Experience with Six Sigma or other operational excellence programs

 

Nice-to-Have

  • Master’s Degree

  • In-depth knowledge of drug substance/drug substance intermediate manufacturing technology

     

 

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 detail 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, MFRs and be able to use a multitude of programs including Excel, Word, Power Point, etc.

 

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

N/A

 

OTHE JOB DETAILS:

  • Last day to apply 5/24/2021

  • Employee Referral Bonus eligible

  • M - F, 1st Shift 8am - 4:30pm

 

 

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.


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