Manager, PX, GWE, LIS Lead
Pfizer
Groton, Connecticut
Full-Time
$99,200
OfficeManager
ROLE SUMMARY
This role will support a wide variety of analytical lab, pilot plant, process and utility equipment used in support of science and operations. This role will perform or manage the repair, maintenance and calibration of the instrumentation and equipment used at the Groton, CT site.
ROLE RESPONSIBILITIES
Communicate with customers regarding service levels and lead the collaboration with science line equipment owners in creating service levels on new/existing GxP laboratory and clinical manufacturing assets
Completes repair/maintenance and calibration tasks and work assignments to effectively manage asset life cycle requirements as well as the site colleague needs.
Collaborate with stakeholders and Subject Matter Experts (SMEs) to establish support models for incoming and outgoing assets
Communicate with management
Collaborate with others to provide service to the site, this may include hard service providers, external service providers, equipment owners, vendors, procurement, etc.
Participate with other site leads or team members
Other related assignments as identified by GWE management as deemed appropriate.
Collaborate with other sites to develop robust programs while driving alignment across the sites.
Ensure compliance (regulatory and safety) during operations.
Maintain site compliance readiness at 100%.
Manage external providers to deliver services in accordance with site and customer requirements.
Manage contracts, service agreements, etc. associated with external vendors utilized to provide support.
Track and manage cost associated with services. Provide input to budget and support to meet budgetary goals and requests.
Perform tasks in a compliant and efficient manner using metrics and Reliability Based Maintenance techniques where available.
Remain current with regulations and service models to meet those regulations.
Serve as the key source of GWE (Global Workplace Experience) Laboratory Instrument Services (LIS) knowledge by providing the necessary support for all compliance activities including but not limited to regulatory body audits, change control, training, and documentation. Drive changes in the program related to audit findings or changes in strategy to support customers.
Provide project support related to assets.
Use Subject Matter Expertise (SME) knowledge to determine make versus buy service strategies based on appropriate cost/benefit analysis.
Set expectations and manage delivery of services provided by contingent staff.
Perform monthly cost allocation for parts utilized in asset maintenance.
Provide mentoring and training to both junior colleague and contingent staff.
BASIC QUALIFICATIONS
Education and Experience:
Applicant must have a bachelor's degree with at least 4 years of experience; OR a master's degree with at least 2 years of experience; OR a PhD with 0+ years of experience; OR as associate's degree with 8 years of experience; OR a high school diploma (or equivalent) and 10 years of relevant experience.
Degree in engineering or scientific discipline, technical certification or equivalent work experience
Experience with asset support in a supervisor or leadership role
Minimum of 2 years of work experience in laboratory environment
Technical/Job-Related Skills:
Possesses a strong understanding of troubleshooting and repair
Coordinate efforts of several groups of individuals
Communicate effectively to diverse audiences
Drive change and hold others accountable
Exceptional people skills
Strong verbal and written communication skills
Initiative-taking/self-starter with ability to multi-task and work effectively with minimal supervision
Proficiency with the Microsoft Office Suite of computer programs
PREFERRED QUALIFICATIONS
Bachelor’s degree in engineering or scientific discipline, technical certification or equivalent work experience
Demonstrated knowledge of the pharmaceutical including R&D laboratory and clinical manufacturing operations
Understanding of FDA and GxP requirements and the drug discovery and development process
PHYSICAL/MENTAL REQUIREMENTS
Due to the nature of work assignments, the Laboratory Instrument Services (LIS) Manager 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 the site for extended periods of time; to push and/or pull objects weighing up to 30 pounds; to lift and carry objects weighing up to 15 pounds; to sit/stand at a computer workstation for extended periods of time. On a frequent basis, essential duties of the position may require the ability to climb stairs, 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 required.
Periodic travel may be required in support of Global Workplace Experience business needs.
Respond to the site in support of business continuity, emergency response and off-shift schedules periodically.
Entry and work in laboratory spaces, GxP aseptic space, mechanical/electrical rooms, Central Utility Plant, services areas such as maintenance shops, shipping and receiving, service corridors with adherence to personal protective equipment practices and procedures as well as aseptic gowning and procedures.
Work Location Assignment: On Premise
Relocation assistance may be available based on business needs and/or eligibility.
Candidates must be authorized to be employed in the U.S. by any employer.
U.S. work visa sponsorship (such as TN, O-1, H-1B, etc.) is not available for this role now or in the future.
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.
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Global Operations