Use Your Power for Purpose

Every day, Pfizer's unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is both flexible and innovative, always putting the patient first. Whether you are involved in development, maintenance, compliance, or research analysis, your contribution directly impacts patients.

What You Will Achieve

You will be a member of Pfizer's dedicated and highly effective quality team. As a Senior Specialist, Digital / CSV ( computer system validation ) and Analytical Equipment Management, your knowledge and skills will contribute towards the goals and objectives of the team. Your focus and ability to meet team targets will help in completing critical deliverables. Your innovative use of communication tools and techniques will facilitate in explaining difficult issues and establishing consensus between teams.

It is your hard work and focus that will make Pfizer ready to achieve new milestones and help patients across the globe.

How You Will Achieve It

• Model a culture of shared accountability, measurable impact and continuous evolution strategic planning

• Contribute to development and socializing of strategic, holistic roadmap with business and IT

• Works on problems of diverse scope requiring skilled analysis of the situation and/or data

• Facilitate stakeholder to prioritize initiatives, balancing fiscal responsibility and urgency

• Socialize and endorse IT governance and processes for discovery, prioritization, and planning

• Partner with IT peers to optimize solution, implementation, and support decisions/approaches

• Contribute to ensuring that IT applications, systems, processes, and personnel are implemented and operated in compliance with global regulations and standards (i.e., GxP, CFR, ICH, GDPR)

• Serves as the validation lead on cross-functional technology initiatives that involve multiple lines of business.

• Uses industry knowledge and best practices to develop validation strategies in harmony with the Quality Unit(s) and following processes that comply with regulations.

• Contributes towards the management and maintenance of processes/procedures defined in the system development lifecycle (SDLC) and Computer Systems Validation (CSV)

• Lead development of risk-based test strategies and plans for systems requiring validation and qualification, and mentor other staff as they develop project test strategies and plans.

• Work creatively and analytically in a problem-solving environment demonstrating teamwork, innovation, and excellence.

• Understand interdependencies between technology, operations, and business needs.

• Support equipment software updates and upgrades by writing/revising, executing, and reviewing software validation test scripts as needed.

• Take lead role and launch change control records for document and/or equipment changes.

• Perform data integrity and impact assessments for equipment and associated software.

• Computer and software configuration

• System /data backup solution configuration

• Routine system administration and ad-hoc issue resolution

• Complete equipment and software periodic reviews

• Create new and review completed equipment records and tasks in the CMMS (computerized maintenance management system) as the System Owner.

• Coordinate with Facilities for scheduling calibration, maintenance, and repairs.

• A few hours of evening, weekend, and/or on-call work may be occasionally required to address equipment alarms.

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.

• Experience in Quality administered systems

• Knowledge of current Good Manufacturing Practices and the applicable GxP regulations and standards

• Proactive approach and strong critical thinking skills

• Must be able to work in a team environment within own team and interdepartmental teams

• Excellent communication and interpersonal skills

• Prior systems validation experience

• Previous experience working with change and configuration management systems

• Excellent written and oral communication skills

• Ability to proactively identify and implement continual improvements

• Ability to work effectively in a fast-paced team environment

• Ability to organize information in a consistent and readily retrievable manner

• Experience working with vendors

• Exceptional planning, coordination, and analytical skills

• Ability to effectively communicate development tasks to non-technical resources and stakeholders

Bonus Points If You Have (Preferred Requirements)

• 10+ years relevant experience

• Relevant pharmaceutical experience

• Compliance knowledge: Strong understanding of software development life cycle in a regulated environment with responsibility to ensure systems are compliant with FDA and global regulations.

• Strategic Thinking: Ability to consider a problem abstractly and develop an approach that meets company strategic goals

• Strategic Planning: Ability to package and syndicate a message, garner business support, drive, and document vision / strategy, plan & organize, providing progress on multiple projects

• Credibility and Presence: The ability to capture the confidence of the organization in presenting new ideas or solutions.

• Collaboration / Communication / Teamwork: Establish and maintain successful interactions within the organization. Ability to build relationships across all levels of the organization with high level of confidence and resiliency.

• Leadership: Ability to take independent action, working with a high-level problem or concept, developing the right next steps to propose resolution, and ensuring successful outcome respectful yet assertive way.

• Outcome Oriented: Balance creativity and innovation against practical / cost effective approaches.

• Willing to lead by example and jump right in, desire to get to root cause, collaborative and active listener

• Effectively manages stressful situations, able to focus on task at regardless of circumstances and stress induced press

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

• A few hours of evening, weekend, and/or on-call work may be occasionally required to address equipment alarms.

Work Location Assignment: On Premise

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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