Senior Validation Engineer

Pfizer Inc.; McPherson (KS); Sur place; USD 83 000 - 138 000; Plein temps

Avantages offerts par ce poste

401(k) with Pfizer Matching

Health benefits

Paid vacation & holidays

Résumé du poste

Pfizer Inc. seeks a Validation Specialist to lead complex projects, drive qualification activities, and ensure compliance with cGMP, ISPE, and 21 CFR Part 11.

You will author protocols, approve reports, and coordinate testing with affected functions. Responsibilities include maintaining the Site Validation Master Plan, supporting regulatory audits, integrating validation into production schedules, and addressing deviations with root-cause analysis and corrective actions.

Qualifications

• Bachelor’s degree with 2+ years experience; or Master’s with more than 0 years; or Associate’s with 6 years; or high school diploma with 8 years of relevant experience.
• Strong understanding of cGMPs, ISPE, Data Integrity, 21 CFR Part 11, industry good practices for IQ/OQ/PQ and SOPs.
• Ability to work independently with limited oversight; strong verbal and written communication skills.
• Desirable: direct validation experience in equipment qualifications, CSV, aseptic validations, process or cleaning validations.

Responsabilités

• Lead completion of assigned complex projects and develop work plans within a team.
• Provide high level data analysis support for Quality Investigations or troubleshooting.
• Lead on-site validation activities, author protocols and final reports, and perform on-floor validations.
• Coordinate and communicate testing with affected groups and evaluate results.
• Maintain Site Validation Master Plan and support regulatory audits related to sterility equipment, capex qualifications, and computerized systems.
• Identify and implement validation best practices to improve site validation program.
• Support product transfers/new development, regulatory queries, and cost-improvement projects in Validation.
• Ensure integration of validation schedule into production schedule and manage deviations with root-cause investigations.

Connaissances

Data analysis

Quality systems

Documentation

Regulatory knowledge

Project coordination

Communication

Formation

Bachelor’s degree

Master’s degree

Associate degree

High school diploma

Description du poste

Use Your Power for Purpose

Every day, our unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our innovative, flexible, 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.

What You Will Achieve

• Lead the completion of assigned complex projects, meet agreed targets and develop plans for work activities on projects within a team.
• Provide high level data analysis support for Quality Investigations or troubleshooting.
• Comprehensive understanding of {Current} Good Manufacturing Practices {part of GxP} guidelines outlined in Code of Federal Regulations.
• Ensure compliance with latest Pfizer Standards for validation and qualification activities.
• Point contact SME for routine Quality systems, such as Change Control, Quality Agreement, Documentation, Submission authoring and Investigations.
• Author or approve protocols and final reports, perform on floor executions of validations.
• Coordinate and communicate all testing with affected functional groups and evaluate test results.
• Maintain Site Validation Master Plan. Support regulatory audits through the preparation and interaction with auditors in areas related to sterility assurance equipment, capex qualifications, computerized systems, process or cleaning validations as assigned.
• Provide expertise for troubleshooting and resolution of issues related to sterility assurance equipment, capex qualifications, computerized systems, process or cleaning validations as assigned.
• Assess potential impact of changes to qualified systems
• Identify and implement validation best practices to continuously improve the site validation program.
• Lead and Support product transfers/new product development, regulatory queries, cost improvement projects or Drug Product plant support for Validation.
• Ensure integration of validation schedule in production schedule for implementation of validation activities and conduct validation deviations, participate in deviation investigations to identify root causes and define corrective and/or preventative actions. Support the unit where needed to assure due dates and customer needs are met.

Here Is What You Need (Minimum Requirements)

• Applicant must have a bachelor's degree 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.
• Strong understanding of cGMPs, ISPE, Data Integrity, 21 CFR Part 11, industry good practices for IQ/OQ/PQ and Standard Operating Procedures.
• Ability to work independently with limited managerial oversight
• Strong verbal and written communication skills

Bonus Points If You Have (Preferred Requirements)

• 5+ years of direct validation experience in minimum one of these fields of validation: Equipment qualifications, CSV, Aseptic validations, process or cleaning validations.
• Strong technical knowledge and experience with validation/qualification of pharmaceutical processes, equipment, utilities, facilities and/or computer systems as related to sterile products and medical devices
• Exposure to multiple validation workstreams

PHYSICAL/MENTAL REQUIREMENTS

• Requires routine sitting, standing, walking, listening and talking
• Acute mental and visual attention at all times
• Handle multiple projects while managing frequent interruptions
• Requires moderate lifting or moving up to 25 pounds (lbs)

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

• Requires regular onsite attendance
• Must have the ability to work effectively under strict deadlines
• Must be able and willing to work beyond office hours which may include weekends and holidays
• Must be capable of supporting up to 10% travel (domestic and international)

Work Location Assignment: On Premise

The annual base salary for this position ranges from $82,700.00 to $137,900.00. 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.

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 ActPfizer 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 EligibilityPfizer 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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Quality Assurance and Control