Senior Associate, Engineering Verification

Why Patients Need You

Whether you are involved in the design and development of manufacturing processes for products or supporting maintenance and reliability, engineering is vital to making sure customers and patients have the medicines they need, when they need them. Working with our innovative engineering team, you'll help bring medicines to the world even faster by imagining what’s possible and taking action.

What You Will Achieve

Working with Pfizer’s dynamic engineering team, you will play a critical role in Verification of GMP systems to meet quality standards with a focus on compliance. Your engineering verification skills will help in recommending and implementing improvements, modifications or additions that will help in solving problems. You will review system requirements against industry standards and implement these requirements to help Pfizer complete capital projects on schedule and within budget. You will support the system life cycle documentation for several of Pfizer’s multi-product, process control systems in the manufacturing of vaccines and Gene Therapy components.   

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

• Perform Verification of a variety of systems such as: process equipment, process control systems (DeltaV, PI, BMS), laboratory systems, utilities and facilities for large capital projects, as needed.
• Lead and/or participate in the planning, preparation, and execution of Commissioning, Qualification and Verification life cycle documentation to align with industry standards and company policies.
• Evaluate and support system audit trails, data integrity, and alarm management requirements.
• Support supplier technical audits and Pfizer corporate audits.
• Support capital projects by performing vendor audit, traveling to FATs, attending SATs, reviewing commissioning and verification protocols, deviations and proposing corrective actions.
• Provide recommendations for improvements with a focus on compliance.
• Generate and revise standard operating procedures and job aids.
• Execute work independently, work with various groups across the organization, and be able to oversee and lead projects to ensure cGMP automated systems perform as intended.

Qualifications

Must-Have

• Applicant must have eight years of relevant experience; OR an Associate's degree with six years of experience; OR a Bachelor’s degree with at least three years of experience; OR a Master’s degree with more than one year of experience.  
• Demonstrate experience with computer or equipment systems within the pharmaceutical industry.
• Knowledge of cGMP (current Good Manufacturing Practices) and industry standards.
• Experience writing or executing GMP documentation.
• Problem-solving skills, task management skills, and ability to manage priorities under pressure
• Ability to work independently or across departments, as needed.

Nice-to-Have

• Commissioning, Qualification or Verification computer or equipment systems experience.
• Experience writing system life cycle documentation.
• Experience with data integrity, audit trail evaluations, alarm management and the verification process.

PHYSICAL/MENTAL REQUIREMENTS

Position requirements are typical for an office-based work environment with routine excursions to job sites and utility or manufacturing areas.  There are no unusual physical or mental requirements for this position.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

The incumbent in this position would typically work a routine weekly work schedule but travel to other Pfizer sites, industry conferences and other events would be normal and expected.  Night or weekend work may occasionally be required to meet project deadlines.

Work Location Assignment: Flexible

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

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.

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