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Why Patients Need You

The success of our breakthroughs reaching patients is a testament to our pharmaceutical manufacturing team. We depend on a group of committed and nimble individuals who grasp the significance and influence of their contribution to Pfizer's mission. Patients require colleagues who are proud of their work and constantly strive to enhance results. Your role is crucial in guaranteeing that patients and physicians receive the necessary medicines at the right time.

Position Summary

The Senior Associate, Calibration & Maintenance CRD-M supports the Chemical Research and Development Manufacturing (CRD-M) Team in Groton, CT. This role is part of Pfizer R&D and has primary responsibility for the planning, scheduling, and execution tracking of the CRD-M Calibration and Maintenance Program. This role will report to the Compliance & Manufacturing Support Lead.

As the Senior Associate, Calibration & Maintenance CRD-M you will be responsible for coordinating and collaborating with staff from CRD-M, Drug Product Supply Manufacturing, Global Workplace Experience, and other relevant groups to ensure the timely execution of cGMP and EHS compliant Calibration and Maintenance activities. This includes managing Work Order Planning, scheduling, assignment, and review. A critical duty of this role is the monitoring of Calibration and Maintenance program health through the development and reporting of metrics. Additionally, this position requires managing Manufacturing Investigations and Change Management related to calibration and maintenance, as well as the creation of Standard Operating Procedures (SOPs). The role involves direct interaction with support lines and the use of Pfizer's software tools (EAMS, eQMS, Trackwise, GDMS, etc.) to perform these tasks.

Role Responsibilities

• Maintain current knowledge of regulatory requirements and the Pfizer compliance environment to be able to perform activities defined above and provide asset management guidance to key stakeholders.

• Develop and maintains robust working relationship with Manufacturing, Engineering, and Quality support groups.

• Serve as the primary CRD-M EAMS superuser and EAMS Maintenance Engineer access role.

• Develop, extract and report metrics/ key performance indicators to measure program health and compliance.

• Collaborate with CRD-M Management to coordinate calibration and maintenance activities around manufacturing schedules and facility shutdowns.

• Responsible for the timely completion of quality incident investigations, including root cause determination and effective Corrective and Preventative Action determination.

• Author Standard Operation Procedures.

• Participate in equipment and computer system validation lifecycle activities to include commissioning, qualification, periodic review, retirement, and change management.

Qualifications

• Associate's degree and minimum 6 years' related experience.

• Direct, functional experience with current Good Manufacturing Practices (cGMP).

• Expertise with the Pfizer Enterprise Asset Management System (EAMS).

• Direct experience working in a cGMP pharmaceutical manufacturing organization.

• Demonstrated ability to holistically organize and schedule work to further Team objectives.

• Candidate must possess effective oral and written communication skills.

• Candidate must function proficiently in a digital work environment.

• Demonstrated competency with the Microsoft Office suite of products.

• Awareness of Continuous Improvement/ Lean Manufacturing methodologies (Six Sigma, 5S) preferred.

• Awareness of the pharmaceutical product development continuum preferred.

• Ability to support Quality and Compliance deliverables in the larger CRD-M organization preferred.

PHYSICAL/MENTAL REQUIREMENTS

Candidate must be physically capable of sitting or standing for prolonged periods, be amenable to wearing personal protective equipment, and working in proximity to manufacturing equipment and hazardous materials.

Work Location Assignment:On Premise

The annual base salary for this position ranges from $74,900.00 to $124,800.00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 7.5% 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.

Manufacturing