Senior Associate Process Engineer, Gene Therapy Manufacturing
Location
Sanford, NC | United States
Job description
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 As a member of the Gene Therapy Operations team located in Sanford, NC, the Drug Product Process Engineer will play a pivotal role in the start-up and ongoing operations to support the gene therapy production facilities in Sanford, NC. Scope of work will include process performance monitoring, support for change controls and deviations as well as identification and implementation of process improvements.
The incumbent will be knowledgeable of process equipment and systems, production operations, automation control (Delta V, etc) and provide direct production support during processing operations. Services include review of process requirements and evaluation of equipment and systems to ensure deliverables meet or exceed process specifications and manufacturing requirements. The incumbent will assist with production planning and provide / support coordinating production activities working with the production area leads. The incumbent will provide technical guidance and training on process equipment and automation systems to production colleagues. The position of Process Engineer requires direct production support.
The incumbent provides process engineering support of cGMP clinical and /or commercial manufacturing processes and equipment. Analyzes repeated issues with equipment. Provides process engineering support to ensure operational success of the maintenance coverage program.
The successful candidate conducts all activities and makes decisions that are in accordance with Company policies & SOPs, Pfizer Values, & global regulatory guidelines (including cGMP/cGLP/cGCP), environmental guidelines, as appropriate, etc. He or she will advise management of non-conformance issues and opportunities for continuous improvement via data trend analysis, interpretation of data, gap analysis and implementation of corrective activities. The incumbent provides input on decisions for SOP's, batch records, forms or other cGMP related documents developed or revised to support continuous improvement efforts, investigation corrective actions, process descriptions, manufacturing operations, automation control (DeltaV, etc.) and regulatory audit commitments.
Further responsibilities include supporting and formally writing manufacturing investigations to support deviations, reviewing and revising cGMP documents, conducting formal site risk assessments, and participation in site change control.
How You Will Achieve It - Contribute to the completion of projects, manage own time to meet agreed targets and develop plans for short-term work activities on own projects.
- Work closely with technical services to develop and confirm Critical and Key Process Parameters needed for Equipment and Process Validation.
- Report team progress, highlight risks, clarify issues, suggest recommendations and present next stage development plans.
- Operate process equipment, such as fermenters, recovery equipment, depth filtration equipment etc.
- Coordinate, schedule & participate in daily activities of (Current) Good Manufacturing Practices (part of GxP) production in the manufacturing area to meet supply chain needs.
- Facilitate effective project meetings with internal team members and with customers.
- Develop SPC (Summary of Product Characteristics) charts for continuous process monitoring and control.
- Develop and maintain project finances and provide information to support financial reporting requirements and cycles.
- Ensure that the process adjustments are incorporated into the appropriate final version of SOPs, Master Batch Records and Compounding Records.
- Provide trouble shooting and technical support to Pfizer manufacturing groups as required.
- Responsible for participating in the execution of process and cleaning validations as well as related activities and projects including continued process verification.
- Adhere to site safety standards, participate in routine safety training events, and enforce safety and biosafety requirements as they relate to the manufacturing department.
- Spends majority of time on the production floor to proactively identify areas for improved efficiencies and ensure that product quality is maintained through all phases of production including operational parameters of manufacturing equipment, automation control, processing dynamics, and integrated utilities to identify and resolve quality, and technical, risk to manufacturing. Serve as the areas technical SME and develops expertise in various manufacturing operations and processes including automation controls that operate and monitor the processes.
- Requires in-depth knowledge of scientific principles, technical knowledge of production equipment, automation control systems, processing requirements and any related procedural requirements with emphasis on assigned production area.
- Capable of identifying technical problems and solving them with minimal guidance. Ability to analyze operational process issues and automation challenges to recommend / initiate appropriate corrective and preventative actions. Acts as a departmental liaison with primary support groups such as engineering, technical services, quality control, quality assurance, development and utilities. The incumbent will manage / implement process, equipment, and automation changes in support of manufacturing operations
- Primary point of contact for operator support and issue resolution.
- Supports process transfers to the Sanford Gene Therapy facilities
- Authors and contributes to validation plans, protocols and reports
- Supports continuous process verification program
- 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 Must-Have - Applicant must have a High School Diploma (or Equivalent) and eight years of relevant experience; OR an Associate's degree with six years of experience; OR a Bachelor's degree with at least three years of experience; OR a Master's degree with more than one year of relevant experience.
- Experience in GMP biopharmaceutical industry
- Experience with Drug Product Operations strongly preferred
- Basic knowledge of Delta V and PI systems Experience with authoring technical study protocols and reports
- 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
Nice-to-Have - Master or Bachelor Degree in Bioprocessing, Engineering, Biology or related discipline
- Manufacturing experience with single use bioprocessing technologies,
- Previous process transfer experience
- Willing to lead by example and jump right in, desire to get to root cause, collaborative and active listener
- Effectively manages stressful situations, able to focus on task at regardless of circumstances and stress induced pressure
Physical / Mental requirements - Ability to perform mathematical calculations
- Ability to perform complex data analysis
Non-Standard work schedule, travel or environment requirements - Ability to work on weekends if needed
Other job details - Last day to apply: March 13th, 2024
- Employee Referral Bonus eligible
- Relocation support available
Work Location Assignment:On Premise
The annual base salary for this position ranges from $78,000.00 to $130,000.00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 10.0% of the base salary. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life's moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site - U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.
Relocation assistance may be available based on business needs and/or eligibility.
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. This position requires permanent work authorization in the United States.
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