Pfizer
Technical Operations Validation Associate
This job is now closed
Job Description
- Req#: 4900769
Responsibilities include the following activities:
1. Authoring of technical reports (periodic reviews) or assessments (materials or components).
a. Drafting content.
b. Facilitating reviews/seeking feedback from multiple internal or external stakeholders.
c. Planning of timelines with intermediate milestones to meet deadlines.
2. Ability to manage multiple activities simultaneously.
3. Liaise with site functions such as Manufacturing, Planning, QA, QC, Operations, and Regulatory Affairs
4. Participating in right-first-time and continuous improvement relative to supported validation programs (processes or
procedures).
Will be responsible for increasingly more complex projects and responsibilities.
The position requires execution of multiple projects at the same time and good communication skills to keep, peers, and area
management up to date with progress of all projects in order to ensure validations are completed in a timely manner and on
schedule.
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, biochemstry, materials or computer science).
- Skilled in Microsoft Word and Excel.
- Demonstrated experience with technical writing on engineering or science topics.
- Previous exposure/familiarity to computer system periodic reviews,
- Previous exposure/experience with validation programs,
- Previous exposure/familiarity with raw material or single use component qualification,
- Previous exposure/familiarity with GMP documentation in pharmaceutical or medical device industry.
Why Patients Need You
Whether you are involved in the design and development of manufacturing processes for products or supporting maintenance and reliability, technical operations are vital to making sure customers and patients have the medicines they need, when they need them. Working with our technical operations team, you'll help bring medicines to the world even faster by imagining what’s possible and taking action.
What You Will Achieve
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.
These positions will provide validation support to either the Computer System Validation/Computer Software Assurance
program or Raw Materials and Components Qualification programs at Pfizer-Sanford. The incumbent will have strong
technical writing skills, being able to summarize different pieces of technical and compliance information into support
validation or qualification of either computerized systems or raw materials and single use components used to support
clinical and commercial large molecule manufacturing processes (i.e. vaccines, gene therapies, etc) at Pfizer-Sanford.
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
Nice-to-Have
One or more of the following:
PHYSICAL/MENTAL REQUIREMENTS
Position requirements are typical for an office-based work environment. There are no unusual requirements for this position.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Schedule is primarily day shift but may require off-shift work on occasions (which can be handled remotely).
Work Location Assignment: On PremiseLast Date to Apply to Job: December 7, 2023
The annual base salary for this position ranges from $62,800.00 to $104,500.00. 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.
EngineeringEEO & 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.
About the company
At Pfizer we know that great things happen anywhere people come together with one shared goal. And the greatest rewards are sometimes where you least expect them. The future of medicine is happening at Pfizer.