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
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.
How You Will Achieve It
- 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 and/or Packaging/Automated Visual Inspection (AVI) processes and technologies.
- 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.
- Bachelor of Science degree in a technical field such as Electrical, Mechanical or Computer Engineering with a minimum of 8 years experience within a Pharmaceutical Engineering/Tech Services position
Master’s Degree in a technical field such as Electrical, Mechanical or Computer Engineering with minimum 5 years experience within a Pharmaceutical Engineering/Tech Services position.
- Thorough knowledge of cGMP, safety and environmental regulatory requirements.
- Minimum 3 supervisory experience. Managerial experience preferred.
- 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.
- Pharmaceutical or manufacturing experience and strong, demonstrated technical skills exhibited in a cGMP environment are requirements. Specific knowledge of and experience with Drug Product processing and equipment is highly desirable.
- An aptitude for understanding process technology and equipment, decision making ability, and excellent oral and written communication skills are essential. Demonstrated ability to interact effectively with all levels of the organization. Candidate must possess flexibility to respond to changing conditions and priorities.
- Demonstrated understanding of global regulations on data integrity and FDA 21 CFR Part 11 requirements
- Must understand basic manufacturing processes and data recorded both electronically and on paper records.
- Manufacturing experience with demonstrated technical skills related to aseptic and terminal sterilization filling processes are highly desired
- Specific knowledge of and experience with Drug Product processing and equipment is also desired. Equipment may include but is not limited to commodity washers, fillers, depyrogenation tunnels, cappers, vision systems, CIP/SIP processes, RABS/Isolators systems, and SCADA applications for filling operations and/or Packaging processes to include labelers, trayers, Serialization, and check weighers. Automated Visual Inspection equipment to include Eisais, Wilcos and Nikka inspection processes.
- Active Involvement in ISPE and PDA guidelines is a plus.
- Strong understanding of automation systems/applications a plus.
- Remains organized & positive in ambiguous and fast-paced, rapidly changing environment
- Flexible and adaptable to changing priorities, meeting deadlines, and working well under pressure.
- Ability to process complex information and make recommendations with incomplete data set
- 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.
- Able to stand for extended hours for test runs and performance monitoring of processes – will include working within special gowning for cleanroom access
- Able to climb ladders/steps
- Able to lift items of 25lbs
- Capable of data analysis using statistical tools/graphing
- Strategic thinker for issue resolution
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 go within clean room areas requiring special gowning which may include full coverage gowning for Aseptic environments.