Technical Operations Engineer

Use Your Power for Purpose
Every day, everything we do is driven by an unwavering commitment to delivering safe and effective products to patients. Our flexible, innovative, and customer-oriented quality culture is rooted in science and risk-based compliance. Whether you are engaged in development, maintenance, compliance, or analysis through research programs, your contribution will have a direct impact on patients. Our dedication to quality and safety ensures that we consistently meet the highest standards, making a meaningful difference in the lives of those we serve. Join us in our mission to improve patient outcomes through excellence in every aspect of our work.
What You Will Achieve
In this role, you will:

• Evaluate, review, and approve validation master plans, protocols, and reports, ensuring compliance with regulatory requirements and company policies.
• Troubleshoot validation problems for equipment and performance processes, conducting statistical analysis of testing results to address process anomalies.
• Write, review, and approve validation process documents and technical reports related to equipment, products, and processes.
• Contribute to project tasks and milestones, organizing work to meet deadlines and applying basic team effectiveness skills within the immediate Work Team.
• Make decisions within limited options to resolve basic problems, working under the supervisor's direction and seeking guidance from colleagues.
• Ensure work is regularly reviewed for technical judgment, completeness, and accuracy, exercising judgment with reliance on the supervisor.
• Determine the process capability of new equipment through the execution of approved protocols, incorporating defined parameters into operating procedures and batch records.
• Assist with the development of validation protocols, manage regulatory queries and responses, and participate in deviation investigations to identify root causes and define corrective and preventative actions.
• Adhere to all company and Good Manufacturing Practices (cGMP) procedures, safety regulations, and participate in the development of validation programs to stay current with cGMPs and industry standards.
• Work effectively as a member of the Quality Operations (QO) cGMP training team, collaborating with Business Area Training Leads, Coordinators, and SMEs to support cGMP and site training initiatives, reporting to the Validation Section Manager and summarizing data into concise reports for review and approval.

Here Is What You Need (Minimum Requirements)

• Applicant must have a bachelor's degree with any years of experience, or an Associate's degree with 4 years of relevant experience, or a high school diploma (or equivalent) and 6 years of relevant experience
• Excellent attention to detail and a solid understanding of Food and Drug Administration Regulations/Guidance and Good Manufacturing Practices
• Strong organizational skills and the ability to manage changing deadlines
• Proficiency in Microsoft Office, particularly Excel, for data evaluation
• Strong written and verbal communication skills
• Ability to work in a team environment and collaborate effectively with colleagues
• Basic understanding of validation principles and practices

Bonus Points If You Have (Preferred Requirements)

• Technical writing experience, particularly within the pharmaceutical industry
• Laboratory process validation expertise
• Working knowledge of equipment qualification and calibration, especially for laboratory equipment
• Experience with regulatory queries and responses
• Excellent interpersonal skills and the ability to work collaboratively with cross-functional teams
• Adaptability and flexibility in a dynamic work environment
• Commitment to continuous learning and professional development

PHYSICAL/MENTAL REQUIREMENTS
Ability to perform mathematical calculations and perform complex data analysis.
Non-Standard work schedule, travel or environment requirements

• Schedule is primarily day shift but may require off-shift work on occasions.
• The position may require working on the floor in manufacturing at times which will require a heightened safety awareness and aseptic gowning will be required.

Other job details:

• Work Location Assignment: Hybrid
• Last day to apply: August 22nd
• No relocation support

The annual base salary for this position ranges from $66,500.00 to $110,900.00. 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.
Pfizer endeavors to make www.pfizer.com/careers accessible to all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process and/or interviewing, please email [email protected] . This is to be used solely for accommodation requests with respect to the accessibility of our website, online application process and/or interviewing. Requests for any other reason will not be returned.
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