Why Patients Need You
Every day, our unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our flexible, innovative, and customer-oriented culture is rooted in science and risk-based compliance. Whether you are engaged in development, maintenance, compliance, or research analysis, your contributions have a direct impact on patient care. By being part of our team, you help uphold a quality culture that adapts and evolves to meet the needs of patients, ensuring that every product we deliver meets the highest standards of safety and efficacy.
What You Will Achieve
The Asset Lead is responsible for asset lifecycle management and technical direction for design, installation, startup/validation, testing, operation, maintenance, and decommissioning of cGMP instruments and equipment used in the Quality Control Laboratories at Andover, Massachusetts site. Primary responsibilities include lifecycle management of QC assets from capital planning to decommissioning, ownership and accountability of QC tracking metrics in site CMMS (EAMS), management of instrument / equipment reliability, support of electronic data reconciliation actions, and support of documentation across instrumentation processes (instrument validation Operation and Maintenance SOP authoring and support, creation / revision of procedures in support of QC instrument lifecycle milestones, project management support throughout instrument lifecycle, review and approval of instrument documentation).
The QC Asset lead will support instrument lifecycle project work, DI / site initiatives, Capital Planning, instrumentation documentation, and technical/CI projects and coordinate support across Site Technical Services and Quality Control Laboratory teams.
How You Will Achieve it
The Asset Lead is accountable for the lifecycle management of QC instruments and equipment
Ownership and accountability of QC tracking metrics in site CMMS (EAMS)
Management of instrument / equipment reliability
Supports priorities related to instrument purchase, validation, and decommissioning in conjunction with STS-IV and QC Laboratory teams
Provide technical direction and robust design solutions to ensure continuous reliable and safe operation of assets for end users
Prepare capital investment requirements to maintain asset reliability
Supports the QC Instrument plan and QC instrument performance by establishing quality standards, developing operations, maintenance, and quality procedures and supporting cross-functional instrument lifecycle project work
Leverage site project management and change management procedures to revise quality documents, SOPs, preventive maintenance strategy with site partners, support Change Control implementation, and support investigation / deviation resolution
Support the establishment of instrument maintenance programs
Leads and manages complex projects
Coach, mentor, train team members across functional areas on new technology / instrumentation and guide them through lifecycle processes
Authors and/or reviews routine to highly complex instrument deliverables [Validation Plan, Validation Strategy, Requirements Specification, Qualification Protocols (IQ,OQ, PQ), Operation and Maintenance SOPs, Change Control Implementation Plans and Impact/Risk Assessment, deviations, investigations, corrective actions and/or preventive actions for adequacy, logic and quality/validation/regulatory impact], for appropriateness, completeness and alignment with quality, validation and regulatory expectation, providing sounds quality and compliance judgment to ensure meeting Pfizer Quality Standards, 21 CFR Part 11, ICH, MHRA, WHO guidance
Provides project management support throughout instrument lifecycle / provide regular updates on instrument lifecycle to QC management
Support of instrument decommissioning projects
Support electronic data reconciliation actions
Plan and coordinate validation / qualification / maintenance / decommissioning deliverables and actions with applicable end user
Exercises judgment in supporting resolution of moderate to high impact/complex instrument/equipment issues
Maintain cGMP compliance and laboratory inspection readiness in regard to instrumentation and DI
Collaborate with colleagues and site functional areas to drive department, quality, and site goals and objectives
Work with Project and Contract Management Group to procure outside services
Support resolution of deviations to protocols and investigations
Support a continuous improvement culture across instrumentation processes
Qualifications
Must-Have
Applicant must have a bachelor's degree with at least 2 years of experience; OR a master's degree with 0+ years of experience; OR an associate's degree with 6 years of experience; OR a high school diploma (or equivalent) and 8 years of relevant experience.
Knowledge and practical application of relevant cGMP principles as they pertain to instrument lifecycle and management of budget (e.g., capital)
Experience in instrument validation / qualification / maintenance / decommissioning in regulated environment
Demonstrated ability to purchase, install, validate, and/or decommission QC instruments
Knowledge and practical application of relevant cGMP principles as they pertain to instrument lifecycle
Demonstrated knowledge in data integrity principles and how to apply them to instrumentation
Knowledge of cGMP, industry standards and regulatory requirements
Self-motivated with the ability to adapt to rapidly changing project priorities and work collaboratively on a cross-functional team
Ability to communicate effectively with site leadership, stakeholders, end users, plant partners, engineers, and maintenance persons
Proficiency with computer systems (Microsoft Office applications, LIMS, etc.)
Excellent communication skills (oral and written)
Nice-to-Have
Knowledge in the application of statistical tools, root cause analysis and/or six sigma methodologies
Understanding of continuous improvement tools and skills (standard work, visual management, DMAIC)
Change Control experience
Project management experience
Knowledge of computer system hardware, infrastructure and networks
PHYSICAL/MENTAL REQUIREMENTS
Normal lifting, sitting, standing, and walking requirements to facilitate support of staff in the office and in the laboratories. Position is first shift Monday through Friday.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Work schedule is first shift, Monday - Friday.
Work Location Assignment: Hybrid
OTHER JOB DETAILS
- Last Date to Apply for Job: April 3, 2025
- Referral Bonus Eligibility: YES
- Eligible for Relocation Package: NO
The annual base salary for this position ranges from $80,300.00 to $133,900.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 10.0% of the base salary. 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.
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.
Quality Assurance and Control
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