The Instrumentation and Controls Compliance Team Lead will manage and ensure that an effective compliance system exists for calibration/instrumentation-related procedures, documentation, computer management, investigations, and management of Instrumentation Standards. The colleague will coordinate with Instrumentation Management oversight and complete related internal/external auditing and reporting to maintain instrumentation is in full regulatory compliance. This position will also serve as the Instrumentation primary contact for internal and external audit preparations, communications, and presentations. Strong specialized skills in computer data/management systems, training, documentation, administration and organization are required. Other related duties may be assigned related to ensuring compliance.
ROLE RESPONSIBILITIES:Leads and completes Instrumentation Investigations in eQMS for instrument standard calibration events, assigned CAPAs, and assigned Effectiveness Checks.
Review and provide feedback on all calibration/instrumentation related investigations
Approves/completes/coordinates the completion of change control action items
Conducts internal audits, periodic reviews, and creates/edits instrumentation procedures (SOPs and Tasks) to ensure documents and the calibration program meet the quality plan and compliance expectations
Acts as the Instrumentation Subject Matter Expert (SME) in internal and external audits
Ensures instruments are of adequate accuracy for their intended purpose (4:1 accuracy ratio, guard-banding, etc).
Serves as the primary calibration coordinator in reviewing and approving added, changed, and decommissioned instrumentation records and CCMS (Computerized Calibration Management System) assets for project support
Lead for generation, queries, reports, and performs analyses on site CCMS data to support departmental, organizational, site tasks, objectives, and maintain GMP Compliance
Supports, recommends, and implements new calibration standards for use by the instrumentation department
Support coordination of vendor calibration program and qualify vendors in the Supplier Management system
Develop and maintain technical instrumentation training program and act as the trainer for instrumentation and site CCMS user colleagues.
Primary interactions will be with Instrumentation, Utilities, Maintenance, and Manufacturing Focus Factories. Position requires interfacing with Project, Process Engineering, and Validation colleagues for the instrumentation requirements on development, installation, issues, and qualification of processes. Additional interactions with Quality and other site departments/colleagues will be required but less frequent.
Required:Applicant must have a bachelor's degree, science discipline preferred, with at least 2 years of experience; OR a master's degree with more than 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.
BS/BA Degree (science discipline preferred)
Experience in Pharmaceutical Instrumentation environment
Experience in Pharmaceutical Instrumentation project validation support
Experience in Pharmaceutical and/or Industrial Computerized Maintenance Management Systems
Pharmaceutical and/or Industrial technical SOP writing experience
Working knowledge of FDA regulations and cGMP experience
Strong oral and written communication, presentation, interpersonal skills
Preferred:High level of computer skills required in MS Office, Word, Excel, SQL, SAP Business Objects Reports, and/or CMMS
Calibration or Maintenance Planning/Maintenance program management and/or improvement experience
Instrumentation, process, validation experience
Proficiency in Enterprise Asset Management System software
Prior investigation writing experience (with determination of product impact)
Organize data, extract key information and creation of technical summary reports.
Superior problem solving /troubleshooting skills
Knowledge of various quality tools
Ability to interface with multiple levels of people in the organization, including plant personnel and senior management
PHYSICAL/MENTAL REQUIREMENTS
Physical requirements include: Lifting (up to 50 pounds), sitting, standing, walking, twisting, bending, and climbing ladders.
Mental requirements include: Using computer terminal 6+ hours/day, ability to perform mathematical calculations, ability to perform complex data analysis, and ability to perform computer data entry.
Other:
Working around moving equipment
Working with chemicals or gasses
Wears specialized Personal Protective Equipment/Clothing
Works in hot or cold environment
Works in hearing conservation area(s)
Works with laser
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Expected to work weekends, off-shift, and call-ins 24/7 as required.
Expected to work numerous consecutive days during plant shutdown periods.
Minimal travel for offsite training opportunities
Standard Monday -Friday work schedule and expected to work overtime, weekends, and consecutive-day shutdown periods. Expected to be available for on-call work as needed. Must adhere to safe work practices. Minimum travel for offsite training opportunities, <10%.
Work Location Assignment: On Premise
OTHER JOB DETAILS
Last Date to Apply for Job: August 20, 2025
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.
Pfizer endeavors to make www.pfizer.com/careers accessible to all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process and/or interviewing, please email disabilityrecruitment@pfizer.com. This is to be used solely for accommodation requests with respect to the accessibility of our website, online application process and/or interviewing. Requests for any other reason will not be returned.
Engineering