Instrument Validation Manager

Why Patients Need You

Pfizer's purpose is to deliver breakthroughs that change patients' lives. Research and Development is at the heart of fulfilling Pfizer's purpose as we work to translate advanced science and technologies into the therapies and vaccines that matter most. Whether you are in the discovery sciences, ensuring drug safety and efficacy or supporting clinical trials, you will apply cutting edge design and process development capabilities to accelerate and bring the best - in - class medicines to patients around the world.

What You Will Achieve

In your role, you will be at the center of Pfizer's operations, and you will find that everything we do, every day, is in line with an unwavering commitment to quality. Your work will help Pfizer in the critical area of portfolio management for our Research and Development (R&D) function. You will work as part of a team which designs and implements business processes to enable product research and development, portfolio prioritization, resource allocation and risk management.

As a Manager , you provide guidance to operational teams for managing projects. Your planning skills will help in preparing forecasts for resource requirements, and providing areas of improvement for products, processes or services. Through your comprehensive knowledge of principles, concepts and theories of the discipline, you will also work towards advancing new concepts and methodologies. You will be able to take a leadership role to facilitate agreements between different teams.

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

How You Will Achieve It

• Provide guidance to and lead moderate to complex projects .
  
• Execute qualitative and quantitative instrument and software validation support R&D product development efforts.
  
• Drive GMP system life cycle projects as the lead validation manager to support the lab with potentially accelerated timelines.
  
• Determine change control needs and provide change control management of GMP analytical instrumentation, equipment, systems and associated services.
  
• Provide analytic support for the implementation of key performance-based metrics to ensure consistency in understanding and application across Pfizer, enhancement of R&D productivity, and optimization of financial investments in those assets that have the best opportunity to transform the lives of patients.
  
• Identify opportunities for applying a resource optimization approach to incremental value creation (acceleration, cost reduction, increased patient benefit) and the development of compelling high-impact product concepts.
  
• Stay current on Good Manufacturing Practices ( cGMPs ) guidelines, Good Laboratory Practices (GLPs), and exhibiting best practices within manufacturing, testing, safety, compliance, investigations and procedures.
  
• Provide support and mentorship to more junior team members, contractors and resources within the team.
  
• Communicate with customers as necessary in order to progress work in a timely and appropriate fashion .
  

Qualifications

Must-Have

• Bachelor's Degree (BA/BS) and 5+ years of experience .
  
• Excellent oral, written and interpersonal skills.
  
• Proficiency in all Microsoft Office programs.
  
• Strong project management skills.
  
• Advanced analytical thinking and data analysis skills.
  

Nice-to-Have

• Master's degree (MA/MS/MBA) and 3+ years of experience .
  
• Doctoral Degree (PhD/PharmD/JD) .
  
• Experience with UV, HPLC, pH, Endotoxin, PCR and other similar laboratory instrumentation and methodologies .
  

Other Job Details
Work Location Assignment:On Premise

On Premise colleagues work in a Pfizer site because it's needed to get their job done. They may have flexibility to work remotely from time to time, but they are primarily on-site.

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Relocation assistance may be available based on business needs and/or eligibility.

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Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.

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.

Research and Development