24 days old

Lead Engineer Operations & Maintenance

Chapel Hill, NC 27514
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".


The Lead Engineer - Operations & Maintenance 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 South Region 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 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 utilities budget 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.


+ 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 operations, maintenance programs and projects for systems including but not limited to purified water, HVAC (heating, ventilation & air conditioning), power distribution, steam, chilled water and other facility support systems. This includes both the reactive and preventive maintenance programs and activities.

+ Oversee and ensure the Reliability Maintenance Program for all GWS equipment and systems is optimized to support the site's manufacturing and laboratory operations as required.

+ Conduct Monthly Joint Review (MJR) meetings with the third-party facilities maintenance provider for communication and planning purposes including the review and alignment on monthly Key Performance Indicators (KPIs) and relevant Service Level Agreements (SLAs).

+ Manage all facility equipment and/or system excursions using Pfizer's Medgate reporting system and the associated CAPA measures based on sound root cause analysis.

+ Optimize energy consumption, utility costs and conservation with the goal of being a good corporate steward of resources and continued cost savings.

+ Provide input, supporting documentation and monitoring of the site's utility costs versus budget.

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

+ Provide input and supporting documentation regarding strategic and tactical planning efforts for space standards, service levels, asset utilization and productivity programs.

+ Execute both capital and expense projects supporting manufacturing, laboratory operations and facilities and site infrastructure.

+ Provide technical and project 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.

+ Perform property audits and collaborate with other facility team members to accomplish departmental objectives.

+ Serve as the primary point of contact and Pfizer interface with the Imperial Center Business Park Owner's Association.

+ 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 educational opportunities; reading professional publications; maintaining personal networks; participating in professional organizations.


**Education and Experience**

+ Bachelor's Degree in Mechanical or Chemical Engineering

+ Minimum of eight years of experience:

+ Providing expertise in the design, installation and maintenance of mechanical 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 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

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

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

+ Possess broad analytical and problem-solving skills

+ Possess a broad understanding of contract administration, business principals and business law

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


+ Knowledge of aseptic manufacturing and support systems

+ Possess knowledge of FDA codes applicable to the pharmaceutical industry

+ Possess an excellent understanding of project management methods, procedures and controls

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


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.


+ 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

**Other Job Details:**

+ **Last Date to Apply for Job: February 25, 2021**

+ 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



Posted: 2021-02-01 Expires: 2021-03-19

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Lead Engineer Operations & Maintenance

Chapel Hill, NC 27514

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