24 days old

Process Engineer, Gene Therapy Manufacturing Technical Services

Pfizer
Sanford, NC 27330
**ROLE SUMMARY**

As a member of the gene and cell therapy technical support team located in Sanford, NC, the Process Engineer will play a pivotal role in the start-up and process transfer to the gene therapy manufacturing facilities in Sanford, NC. During the initial phase this role will focus on supporting the gene therapy facility start-up, process transfers and process validation. Following execution of process validation the scope of work will include process performance monitoring, support for change controls and deviations as well as identification of process improvements.



**ROLE RESPONSIBILITIES**



+ 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.

+ Authors process descriptions, process flow diagrams and risks assessments.

+ Supports change management and implementation for changes to the manufacturing processes and associated systems. Owns change controls related to process changes.

+ Identifies potential process improvements projects. Leads implementation of process improvements projects and supports compliance driven projects that require technical support.

+ Supports process transfers to the Sanford Gene Therapy facilities

+ Authors and contributes to process validation plans, protocols and reports

+ Supports continuous process verification program

+ Benchmark and monitor process performance using statistical tools

+ Independently learn new systems and software needed for process monitoring and lead implementation of such

+ Recommend new approaches for data monitoring based on subject matter expertise



**QUALIFICATIONS**



+ Master or BS in Bio processing, Biomedical Engineering, Biology or related discipline is required.

+ BS with a min of 3-5 years or MS with min of 1-2 years, of relevant experience in GMP bio pharmaceutical industry

+ Downstream Process development and/or technical support for GMP downstream manufacturing

+ Basic knowledge of Delta V and PI systems Experience with authoring technical study protocols and reports including process validation studies

+ Statistical knowledge to analyze process data and experience with statistical software used for process monitoring

+ Strong leadership, organizational planning and project management skills, in addition to technical knowledge, is required to work with multi-disciplinary teams.

+ Must be self-motivated and work with minimum direction

+ Excellent interpersonal effectiveness and communication skills (written and oral) are required in order to interface across management levels and departments.

+ Ability to focus on specific production processes with great attention to details



**Preferred**



+ Manufacturing experience with single-use bioprocessing technologies

+ Experience with database management

+ Previous process transfer experience



**PHYSICAL/MENTAL REQUIREMENTS**



+ No unique physical requirements



Mental:

-Remains organized &; positive in ambiguous and fast-paced, rapidly changing environment

-Flexible and adaptable to changing priorities, meeting deadlines, and working well under pressure and in ambiguous situations

-Ability to process complex information and make recommendations with incomplete data set



**NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS**

Ability to adjust work schedule to meet business needs - overtime, off shift, weekends.

Ability to travel- travel time may be up to 20% according to business needs.



+ Last Date to Apply for Job: 5/10/2020

+ Eligible for Employee Referral Bonus



**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.



Engineering

Categories

Posted: 2020-04-30 Expires: 2020-05-30

Before you go...

Our free job seeker tools include alerts for new jobs, saving your favorites, optimized job matching, and more! Just enter your email below.

Share this job:

Process Engineer, Gene Therapy Manufacturing Technical Services

Pfizer
Sanford, NC 27330

Join us to start saving your Favorite Jobs!

Sign In Create Account
Powered ByCareerCast