Validation Associate Tech Ops- CSV at Pfizer in Sanford, North Carolina

Job Description:

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

 

Pfizer Sanford provides Drug Substance and Drug products to facilities around the globe. This position works as part of a cross-functional team to perform technical tasks as they relate to support for different validation program efforts, including equipment validation, computer system validation, process validation cleaning validation . These validation efforts will help ensure that our equipment, systems, and processes are reproducibly functioning as intended to support our efforts to manufacture medicines for patients. As an associate, your focus on the job will contribute to achieving project tasks and goals. Through your domain knowledge and commitment, you will create a collaborative team environment for your colleagues.

 

How You Will Achieve It

 

• Authoring of technical reports (periodic reviews , validation protocols ) or assessments (materials or components)

• Execution of validation protocol .

• Facilitating reviews/seeking feedback from multiple internal or external stakeholders.

• Ability to manage multiple activities simultaneously.

• Liaise with site functions such as Manufacturing, Planning, QA, QC, Operations, and Regulatory Affairs

• Planning of timelines with intermediate milestones to meet deadlines.

• Participating in right- first-time and continuous improvement relative to supported validation programs (processes or procedures).

 

Qualifications

 

Must-Have

 

• Applicant must have High School Diploma (or Equivalent) with six years of relevant experience; OR an Associate's degree with four years of experience; OR a Bachelor's degree with 0-2 years of experience . Relevant experience/degree must be in engineering or science (for example, biology, chemistry, biochemistry , ma terials o r computer science).

• E xperience with computer system validation life cycle management .

• Skilled in Microsoft Word and Excel.

• Ability to work in a team environment and complete tasks independently.

 

Nice-to-Have

 

• Technical writing and evaluation skills.

• Experience with risk-based approaches (risk assessments).

• Previous experience with E lectronic Validation Document Management System .

• Previous experience with validation of Analytical instruments and Computer System

 

PHYSICAL/MENTAL REQUIREMENTS

 

• Ability to enter and navigate cleanroom type environments in manufacturing facilities.

 

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

 

• Schedule is primarily day shift, but at times it will be necessary to work additional times to support emergency manufacturing needs (either onsite or remote)

 

Work Location Assignment: On Premise

 

The annual base salary for this position ranges from $64 600,00 to $107 600,00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 7,5% 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.

 

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