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.
Manages a staff of engineers to provide technical expertise and operational support for Rocky Mount, NC operations. Provides process engineering support and leadership in the design, start-up, and verification of new equipment/processes at the Rocky Mount, NC Facility. Manges the generation, review and/or approval of technical user requirements and design specifications, allocates appropriate resources and leads efforts to support fit for use activities (commissioning, cycle development and verification), and serves as a process subject matter expert for supporting area(s). Ensures appropriate Engineering support is available for successful qualification/validation efforts, technical transfers, new or changes to commodities, and completion of impact assessments for site changes and owner actions and manages against site commitments. Manages technical team to ensure appropriate support of process performance monitoring for proactive mitigation of quality and process issues that lead to downtime as well as identification and implementation of process improvements. Provides technical expertise and operational support to Operations. Partners with area managers and shop floor colleagues and supervision to ensure smooth and efficient production of a diverse mix of products. Assists in equipment troubleshooting activities as needed. Supports Data Integrity (DI)initiatives and maintenance of DI compliance associated with manufacturing processes and controls.
· Contribute to Project Technical Teams, communicate and collaborate effectively to ensure effective interactions with all stakeholder groups.
· Manages team of engineers to ensure proper design of technical/engineering studies and technical reports summarization of study results and data generation to support process development for new equipment, process changes, commodity changes and/or investigation/CAPA support.
· Completes change impact assessments for site changes as a technical SME.
· Generate/support/review/approve site technical assessments (i.e., alarm, risk, engineering).
· Supports change management and implementation for changes to the manufacturing processes and associated systems.
· Supports and leads technical team to identify potential process improvements projects. Manages implementation of process improvements projects and supports compliance driven projects that require technical support.
· Direct, mentor and train junior colleagues.
· Manage goal setting for direct reports, support achievement of identified goals against site goals, and completion of performance reviews.
· Support review, introduction and/or implementation of new technologies at the site.
· Identifies and leads implementation of cost savings ideas, specifically efficiency improvements and other projects that increase equipment capacity.
· Develops and supports qualification of manufacturing processes for drug products, taking into consideration problems inherent in Terminal Sterilization and Aseptic Filling processes.
· Manages technical support in investigation of deviations that occur on the manufacturing floor. Leads root-cause analysis and identifies appropriate, effective corrective actions. Implements corrective actions in conjunction with the appropriate enabling groups, i.e. engineering, maintenance, quality, validation, operations, EHS, etc.
· Leads technical improvement projects aimed at defect reduction, improved equipment reliability, and better equipment utilization.
· Interface closely with site cross functional teams to specify user requirements and define project scopes.
· Collaborates with and influences other enabling departments (Quality, Engineering, Maintenance, etc.) to assure initiatives are successful.
· Provides concise and thorough updates on initiatives to site leadership.
· Manage responsible work against site approved and/or capital project budget. Manage selection and onboarding of contract resources.
· Knowledgeable of tools and techniques required to manage multiple projects as well as large scale complex projects through multi-disciplinary teams.
· Person will be responsible for interfacing with auditors and presenting on site processes.
· Responsible for maintenance, review and approval of site documents to include calibration reports, batch records, SOP’s, change control, design specs, etc….
· Ensure data integrity practices and procedures are implemented on all systems in Manufacturing for quality compliance and to meet industry standards. Support mapping of data flow for a system- both electronic and paper handoffs.
· Review user access and system audit trails of manufacturing equipment and support/review data integrity investigations.
· Work with internal/external stake holders to improve data integrity by strengthening data capture, reporting and review processes.
- Provide support to Manufacturing and Quality to address data integrity issues identified during data review or audit.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Pfizer operates 24/7 across most of the business units. Employee must have the ability to work extended hours, holidays and/or weekends as needed. Limited travel may be required to support OEM equipment design reviews and/or Factory Acceptance Testing of new equipment. Employee will be expected to periodically work within clean room areas requiring special gowning to include full coverage gowning for TS and Aseptic environments as applicable.
Relocation support available
Work Location Assignment: On Premise
The annual base salary for this position ranges from $106,300.00 to $177,100.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 15.0% of the base salary and eligibility to participate in our share based long term incentive program. 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.
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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.