Senior Associate Process Engineer, Gene Therapy Manufacturing Job at Pfizer
Why Patients Need You
Whether you are involved in the design and development of manufacturing processes for products or supporting maintenance and reliability, engineering is vital to making sure customers and patients have the medicines they need, when they need them. Working with our innovative engineering team, you'll help bring medicines to the world even faster by imagining what’s possible and taking action.
What You Will Achieve
Working with Pfizer’s dynamic engineering team, you will play a critical role in developing and modifying process formulations, methods and controls to meet quality standards. Your production engineering skills will help in recommending and implementing improvements, modifications or additions that will help in solving problems. You will review product requirements in terms of product development compatibility and help Pfizer determine optimum costs and schedules of production.
As a Senior Associate, your knowledge and skills will contribute towards the goals and objectives of the team. Your focus and ability to meet team targets will help in completing critical deliverables. Your innovative use of communication tools and techniques will facilitate in explaining difficult issues and establishing consensus between teams.
It is your hard work and dedication that will make Pfizer ready to achieve new milestones and help patients across the globe.
How You Will Achieve It
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Primary point of contact for operator support and issue resolution
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Responsible for problem diagnosis / root cause(s) determination (automation, mechanical, documentation, training, etc)
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Coordinate activities with PCS to resolve automation issues and changes.
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Coordinate activities with maintenance to resolve mechanical issues
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Supporting and author manufacturing investigations to support deviations.
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Work to develop and actively contribute to GTx process monitoring and verification activities, including benchmarking and monitor process performance using statistical tools.
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Partner with current team to ensure consistency between unit operations.
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Designs technical and engineering studies, writes technical reports summarizing study results, and generates necessary data to support change impact assessments during process transfers and investigations.
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Authors process and equipment descriptions, process flow diagrams and risks assessments.
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Initiate and supports change management and implementation for changes to the manufacturing processes and associated systems. Own change controls related to process changes.
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Identifies potential process improvements projects. Leads and supports implementation of process improvements projects and supports compliance driven projects that require technical support.
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Author and contribute to the development and modifications of operational process and equipment documentation including SOP, Job aid and Master batch records.
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Authors process descriptions, process flow diagrams and risks assessments.
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Supports process transfers to the Sanford Gene Therapy facilities.
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Authors and contributes to validation plans, protocols and reports.
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Supports continuous process verification program.
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Independently learn new systems and software needed for process monitoring and lead implementation of such.
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Recommend new approaches for data monitoring based on subject matter expertise.
Qualifications
Must-Have
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BS in Engineering, Bioprocessing, Biology or related discipline is required within 3-5 years of relevant experience in GMP biopharmaceutical industry
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MS in Engineering, Bioprocessing, Biology or related discipline is required with 1-3 years of relevant experience in GMP biopharmaceutical industry
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Driven to take ownership of equipment and technical issues.
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Keen attention to technical detail.
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Basic knowledge of DeltaV and PI systems Experience with authoring technical study protocols and reports
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Statistical knowledge to analyze process data and experience with statistical software used for process monitoring
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Strong leadership, organizational planning and project management skills, in addition to technical knowledge, is required to work with multi-disciplinary teams.
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Must be self-motivated and work with minimum direction
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Excellent interpersonal effectiveness and communication skills (written and oral) are required in order to interface across management levels and departments.
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Ability to focus on specific production processes with great attention to detail.
Nice-to-Have
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Manufacturing experience with single use bioprocessing technologies.
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Experience in downstream biotechnology processes.
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Previous process transfer experience.
Physical / Mental requirements
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Capable of sitting and/or standing for extended periods of time during the work shift, lifting up to 40lbs.
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Remains organized and positive in fast-paced, rapidly changing environment.
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Flexible and adaptable to changing priorities, meeting deadlines, and working well under pressure and in ambiguous situations.
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Ability to process complex information and make recommendations with incomplete data set.
Other job details
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Last day to apply: 3/27/2023
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Employee Referral Bonus eligible
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Relocation support available
Work Location Assignment: On Premise
Relocation assistance may be available based on business needs and/or eligibility.
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.
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