Manufacturing Process Engineer - Night Shift
Job Description
Why Patients Need You
Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is innovative and customer oriented. Whether you are involved in manufacturing, testing, or compliance, your contribution will directly impact patients.
What You Will Achieve
As a member of the Train 3 Nimenrix Operations team located in Sanford, NC, the Process Engineer (12hour Night Shifts) will play a pivotal role in the ongoing operations of the Train 3 production facility 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 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 daily production and Standard work tasks.
Ensure your shift achieved standard work task and updates the production schedule as needed.
Works 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 implement continuous improvements.
Operate process equipment, such as Ultra Filtration Skids, Mixing columns, 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 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 continuous process verification program.
Independently learn new systems and software needed for process monitoring.
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
Experience with Microsoft Project
General knowledge of scientific principles, production equipment & related procedures
Physical / Mental requirements
Moderate repetitive standing, sitting, bending, ladder climbing, pushing and lifting (up to 40lbs) required on a daily basis.
Ability to perform mathematical calculations and learn new processes/systems.
Be able to support 24/7 manufacturing operation.
Non-Standard work schedule, travel or environment requirements
12-hour (6pm-6am) day shift schedule (2 on, 2 off, 3 on). Works every other weekend.
Other job details
Last day to apply: April 4th 2024
Employee Referral Bonus eligible
Work Location Assignment: On Premise
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.
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.
