Validation Engineer II

Why Patients Need You

Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients.  Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.

What You Will Achieve

You will be a member of Pfizer’s dedicated and highly effective quality assurance team. You will be responsible for evaluation, review and approval of validation master plan, protocols and reports. Your methodological approach will help us ensure compliance of our quality systems with company standards and government regulatory requirements. Your
problem-solving ability will help us troubleshoot validation problems for equipment and performance processes and conduct statistical analysis of testing results and process anomalies. Your documentation skills will guide the writing, review and approval of for validation process documents and technical reports related to equipment, products and processes.

As an associate, your focus on the job will contribute in achieving project tasks and goals. Through your domain knowledge and commitment, you will create a collaborative team environment for your colleagues.

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

• Contribute to the completion of complex projects, manage own time to meet agreed targets and develop plans for work activities on own projects within a team.

• Determine process capability of new equipment through execution of approved protocols and assure defined parameters are incorporated into respective operating procedures and batch records.

• Assists with development of validation protocols and manage Regulatory queries and responses.

• Participate in deviation investigations to identify root causes and define corrective and/or preventative actions.

• Adhere to all company and Good Manufacturing Practices {also cGMP} procedures, along with safety regulations within the plant and participates in developments of validation programs as needed to remain current with cGMPs and industry.

• Work effectively as a member of the Quality Operations (QO) Good Manufacturing Practices {also cGMP} training team as well as directly with Business Area Training Leads / Coordinators and SMEs within Quality to support Good Manufacturing Practices {also cGMP} and site training initiatives.

• Report to the Validation Section Manager, the Validation Engineer will assure that equipment, facilities, and utilities are validated in accordance with {Current} Good Manufacturing Practices {part of GxP} principles, regulatory requirements, and company policies and standards.

• Work on summarization of data into concise reports that is reviewed by the QO product professional and approved by production and quality management.

• Define problems, collect data, establish facts, and draw valid conclusion.

• Work in a team environment to meet all team objectives and communicate progress on scheduled projects.

Qualifications

Must-Have

• Bachelor's Degree in Engineering, Science, or related field

• 2-4 years of experience in Pharmaceutical industry (manufacturing quality or qualification)

• Excellent attention to detail and working knowledge of Food and Drug Administration Regulations/Guidance, and Good Manufacturing Practices

• Excellent organizational skills, and ability to handle changing deadlines

• Strong communication with written and verbal skills

• Working knowledge of Microsoft Office, especially Excel for evaluation of data

Nice-to-Have

• Technical writing experience

• Working knowledge of equipment qualification and calibration

OTHER JOB DETAILS:

• Last day to apply 8/5/2021

• Employee Referral Bonus eligible

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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.

Quality Assurance and Control

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