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 Validation team.
As a Validation Associate Engineer you will be responsible for validating/qualifying the processes, systems, equipment, facilities, and/or utilities used to manufacture and/or clean drug products within a large manufacturing facility located in North Carolina, USA. You will help to demonstrate that the processes and/or systems are running according to necessary specifications and operate within regulations to ensure data integrity and the production of quality products.
As an associate engineer, your focus on the job will contribute in achieving project tasks and goals. Through your domain knowledge and commitment, you will create a collaborative teaming environment for your colleagues. It is your hard work and commitment that will make Pfizer ready to achieve new milestones and help patients across the globe.How You Will Achieve It
- Draft, schedule and execute validations/qualifications per Standard Operating Procedures (SOPs), protocols and regulatory guidelines.
- Coordinates and communicates all testing with affected functional groups and evaluates test results.
- Execute validation activities to include, but not limited to: Change Control initiation, protocol preparation, periodic reviews, routine requalification, scheduling, protocol execution, data review and final report generation.
- Participate and/or present data in Regulatory Agency, Customer, Corporate and Internal audits when necessary.
- Participate in development/ improvements to the validation program as needed to remain current with cGMPs and industry standards.
- Participates on teams assembled to specify, install, validate, troubleshoot and maintain processes, systems and equipment.
- Participates in deviation investigations to identify root causes and define corrective and/or preventative actions (CA/PA).
- .Review and approve Manufacturing and Packaging records to ensure that the information and documentation conforms to Pfizer policy and cGMP's.
- Create, review and approve deviations.
- Help to define appropriate action plans for improvement and follow-up and communicate action closures.
- High School Diploma (or equivalent) with 6 years of relevant experience,
- Or an Associate's degree with 4 years of experience,
- Or a Bachelor's degree with 0-2 years of experience.
- Ability to work in a team environment within own team and interdepartmental teams.
- Effective written and oral communication skills.
- Excellent attention to detail.
- Must be able to interact with varying levels within the company.
- Ability to work both independently and in partnership with others; proven ability to use initiative and drive to achieve results.
- Strong conflict resolution skills.
- Be proactive, have experience with high performance teams, strong interpersonal and project management skills.
- Experience at a pharmaceutical manufacturing site
- Some knowledge and experience with equipment, facility, utility or computer system validation, as related to sterile products and medical devices preferred.
- Experience of writing and managing deviations.
- Experience in production batch record review, investigation of non-conformance, root cause analysis and change control management.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
- Must be able to lift and carry light loads as necessary in conducting testing. Weekend or long hours based on testing schedule.
- May involve standing for long periods of time.
- Must be able to wear proper gowning and PPE in manufacturing areas as required to meet GMP and/or OSHA requirements.
Primary work schedule is Day shift, Monday - Friday, but evening, early morning (off shift), weekend and some holiday work will be required, as needed. Some travel,
Work Location Assignment:On PremiseLast Date to Apply: February 22nd, 2024
The annual base salary for this position ranges from $54,700.00 to $91,100.00. 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.
Quality Assurance and Control