13 days old

Lead Engineer

Pfizer
Chapel Hill, NC 27514
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Come join Pfizer as we build a brand new, state of the art Gene Therapy GMP Phase 1 & II Clinical Manufacturing site in Durham, NC! The site is presently under construction and scheduled for opening Q1 2022. An amazing opportunity to become part of this new team that works toward our mission of "Breakthroughs that change patients' lives".



**ROLE SUMMARY**



The Lead Engineer - Automation & Power Systems provides technical competency in assuming liaison and/or control responsibility for various multidisciplinary activities supporting the overall site operations and colleagues for the Global Workplace Solutions (GWS) - Americas Region II Durham Clinical Manufacturing Facility (DCMF) located in Durham, NC. This entails a diverse range of accountabilities including oversight and direction of vendor and contractor work performed on analytical laboratory equipment, building systems and assets, new designs and installations, operations and maintenance activities, modifications and modernization technologies, as well as the protection of physical facilities and process equipment. Additional accountabilities include the creation and monitoring of the site's automation and power distribution strategies for all facility operations and facility/critical utilities as well as providing strategic input for the site's capital program. The role requires the development and maintenance of close working relationships with colleague and contracted resources to define facility requirements, analyze needs, provide recommendations, and execute plans and options that align with overall GWS goals and supported business line objectives and strategies.



**ROLE RESPONSIBILITIES**



+ Provide engineering support, assistance and oversight for facility operations and site services in regulated cGMP clinical aseptic manufacturing, laboratory and office workspace environments.

+ Oversee daily calibration operations, preventive and corrective maintenance with the Laboratory Instrument Services (LIS) for the Analytical Research & Development (ARD) operations. This will include direct supervision of two (2) LIS Calibration Technicians and coordination with the GWS LIS & ALM (Asset Life Cycle Manager) Lead. Additionally, it will include the oversight and management of contract service providers performing these services. All work activities to be documented using EAMS (Enterprise Asset Management System) which is Pfizer's CCMS (Computerized Calibration Management System).

+ Oversee daily administration, operations, maintenance programs and projects for the following:

+ Primary site automation systems including the Building Management System (BMS), Environmental Monitoring System (EMS), S2 Security and Fire Alarm systems.

+ Discrete and isolated control systems associated with all facilities support and critical utility systems.

+ Primary and back-up electrical power distribution systems

+ Record and administer equipment and calibration excursions and the appropriate CAPA (Corrective And Preventive Actions) as required within Pfizer's Quality Tracking System (QTS).

+ Provide documentation and input for near and long-term capital project planning and execution.

+ Provide automation and electrical support of both capital and expense projects for manufacturing, laboratory operations and facilities and site infrastructure.

+ Provide technical support as appropriate for Risk Management including but not limited to EHS, Security, Emergency Response, Business Continuity, and Compliance.

+ Provide ad-hoc engineering support and technical assistance to Digital/Business Technology in support of the site and its respective colleague groups.

+ Enhance department and organization goals by accepting ownership for accomplishing new and different requests; explore opportunities to add value to job accomplishments.

+ Update job knowledge by participating in internal and external training opportunities; internal communities of practice; maintaining personal networks; participating in professional organizations.



**BASIC QUALIFICATIONS**



Education and Experience



+ Bachelor's Degree in Electrical Engineering

+ Minimum of eight years of experience:

+ Overseeing a calibration program

+ Providing expertise in the design, installation and maintenance of automation and electrical systems specific to HVAC, purified water systems, chillers, boilers, steam and facilities equipment

+ Working in a pharmaceutical cGxP regulated environment

+ Providing engineering operations support and project management

+ Working in a team environment providing critical customer service



Technical and Soft Skills



+ Experience with the design and installation of clinical manufacturing, laboratory and administration work areas, and facility support utility systems in a research and development environment

+ Experience with the programming of PLC control systems, HMI (Human Machine Interface) software, power monitoring software packages and SMART building technologies.

+ Working knowledge of test equipment and diagnostic instruments for automation and power distribution systems

+ Skilled with intermediate networking including the ability to diagnose ethernet and fiber hardware and interfaces

+ Working knowledge power distribution, emergency generation and UPS power systems

+ Possess broad analytical and problem-solving skills including a knowledge with diagnostic, test and repair techniques

+ Experience with Computerized Maintenance Management Systems

+ Ability to prepare design plans, technical reports, evaluations and cost estimates

+ Demonstrated computer skills; Windows operating systems and databases and MS Office Suite (Outlook, Word, Excel and PowerPoint)

+ Ability to present and discuss findings with senior and first level management, colleagues, consultants and non-company officials

+ Possess excellent written, verbal and interpersonal skills



**PREFERRED QUALIFICATIONS**



+ Demonstrated working knowledge of:

+ Aseptic manufacturing and support systems

+ FDA codes for the pharmaceutical industry

+ Project management methods, procedures and controls

+ Demonstrated computer skills; Pfizer specific systems QTS, P2L and EAMS



**PHYSICAL/MENTAL REQUIREMENTS**



Due to the nature of work assignments, incumbents must be able to perform detailed work on multiple, concurrent tasks, with frequent interruptions and under time constraints. On a daily basis, the position responsibilities may require the ability to stoop; to reach; to stand, to walk and sit for extended periods of time; to push and/or pull objects weighing up to 30 pounds; to lift and carry objects weighing up to 50 pounds with reasonable accommodation; to use finger dexterity to operate a computer and other office equipment and hand strength to grasp objects; to perceive the attributes of objects by touch; to hear and verbally exchange ideas and information with colleagues and others on the phone and in the office; to see clearly from less than one foot to arm's length with a good field of vision and to distinguish basic colors and shades of color. On a frequent basis, essential duties of the position may require the ability to climb stairs, climb ladders, to kneel and/or crouch to retrieve items.



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



+ Day shift with occasional after hours or weekend response for onsite support associated with facility incidents or excursions or planned shutdowns for maintenance and/or capital and expense project execution

+ Respond as required to the site in support of business continuity and emergency events

+ Periodic travel may be required in support of GWS business requirements

+ Entry and work inside cGMP aseptic manufacturing spaces, laboratories, mechanical/electrical rooms, maintenance shops, shipping and receiving and service corridors. While working in these areas, strict adherence to aseptic gowning and procedures and personal protective equipment will be required as applicable.

+ General safety knowledge and awareness expected in office, laboratory and manufacturing environments



+ 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.



Global Operations



\#LI-PFE
Posted: 2021-06-07 Expires: 2021-07-08
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Lead Engineer

Pfizer
Chapel Hill, NC 27514

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