Validation Quality Engineer I

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.

ROLE SUMMARY

This position is for an individual contributor to the Quality Operations Validation department. 

The successful candidate will assist in the development of Aseptic product manufacturing equipment qualification/validation, Cleaning Validation & Process validation protocols, performs testing and write validation reports. Generate validation protocols using templates. Primary responsible for protocol execution of various types of basic processing equipment under the direction of Validation Manger.

The position requires knowledge of cGMP and associated industry and regulatory guidance documents. The candidate must have demonstrated proficiency in project management skills and must be able to balance multiple priorities.

How You Will Achieve It

• Assists with development of Aseptic product manufacturing equipment qualification/validation, Cleaning Validation & Process validation protocols, performs testing and write validation reports. Generate validation protocols using templates. Primary responsible for protocol execution of various types of basic processing equipment under the direction of Validation Manger (For example (but not limited to) the following: cleaning (CIP &COP) equipment, washers, sterilizers, depyrogenation oven, fillers, formulation mixing systems, HVAC systems, incubators, freezers, refrigerators and assembly equipment).
• Issue data, memos and reports concerning above projects.
• Help to determine process capability of new equipment through execution of approved protocols and assures defined parameters are incorporated into respective operating procedures and batch records.
• Perform special projects as assigned by department manager.
• Adhere to all company and GMP procedures, along with safety regulations within the plant.
• Assist with validation activities performed by outside validation companies; assures that department and company policies are adhered to.
• Assist with the Site Change Management Program to keep all finished products, equipment, processes and facilities in compliance with contemporary industry standards and regulatory filings.

QualificationsMust-Have

• BS in Chemistry, Biochemistry, Microbiology, Engineering, Pharmacy or related science and 3 plus years related experience and/or training; or equivalent combination of education and experience
• Knowledge of cGMP and internal SOPs and general knowledge of associated industry and regulatory guidance documents.
• Sound working knowledge of the operation of various pharmaceutical processing equipment, labeling/packaging equipment and integrated inspection equipment.
• Ability to read, analyze and interpret common scientific and technical journals; comprehend equipment manuals and translate operational limits into protocols acceptance criteria; able to readily identify/report deviations to management in a timely manner. 
• To perform this job successfully, an individual should have working knowledge of Microsoft Office (Word, Excel, Outlook, Access, and Projects

Nice-to-Have

• Technical writing experience
• Pharmaceutical Industry with laboratory process validation experience
• Working knowledge of equipment qualification and calibration specifically for laboratory equipment

PHYSICAL/MENTAL REQUIREMENTS

• While performing the duties of this job, the employee is occasionally exposed to general laboratory and/or manufacturing areas; work near moving mechanical parts; toxic or caustic chemicals; the noise level in the work environment is usually moderate; required to stand; walk; sit; talk or hear; must occasionally lift and /or move up to 25 pounds; specific vision abilities require by this job include ability to adjust focus.
• Position requires regular onsite attendance – this position cannot be performed on a remote or telecommute basis on a temporary, short or long term basis.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Must have the ability to simultaneously multi-task across multiple capabilities and functions and handle multiple competing priorities and requirements. Must have the ability to work effectively under and manage to strict production, time and performance deadlines. Must be willing and able to work beyond the hours typically defined as a "regular" workday, which may or may not include weekends and holidays. If necessary travel to other locations.

The job is open only to Protected Individuals (as defined by 8 U.S.C. § 1324b(a)(3), namely, Citizens or Nationals of the United States, Lawful Permanent Residents (“green card holders”), Refugees and Asylees.

Last Date to Apply for Job: August 11, 2021

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