Validation Engineer III

Whether you are involved in the design and development of manufacturing processes for products or supporting maintenance and reliability, engineering is vital to making sure customers and patients have the medicines they need, when they need them. Working with our innovative engineering team, you'll help bring medicines to the world even faster by imagining what's possible and taking action.

What You Will Achieve

We are seeking a highly motivated individual for the role of "Validation Engineer III" within Drug Product Supply (DPS) in Groton, CT. Our GMP facilities utilize advanced manufacturing technologies to produce solid oral dosage forms for Phase I - III clinical studies. Manufacturing technologies supported include both continuous and batch processing equipment.

The "Validation Engineer III" will support the Drug Product Manufacturing (DPM) Validation Technical Support team to enable facility and equipment availability and capacity.

The "Validation Engineer III" is an individual contributor role.

How You Will Achieve It

The Roles and responsibilities of the "Validation Engineer III" within Validation Technical Support include:

• Develop a predictive maintenance program, ensuring operational excellence and maximizing up-time.
  
• Contribute subject matter expertise in multiple focus areas (i.e., Automation, Cleaning, Facility Support, Process Development, Capital/Finance, Process Safety).
  
• Scope equipment functional needs alongside operations to ensure user requirements are met.
  
• Perform lifecycle management and deliverable execution of new production equipment (i.e. qualification, validation, and project management).
  
• Write standard operating procedures for new equipment and perform or coordinate training for operations personnel.
  
• Perform change management for existing or legacy manufacturing equipment and systems.
  
• Author and approve cGMP documentation following ALCOA principles and data integrity requirements.
  
• Drive timely resolution of quality deviations and lead root cause analysis or CAPAs for manufacturing investigations.
  
• Propose and lead continuous improvement projects.
  
• Support execution deliverables for the equipment cleaning validation program.
  
• Troubleshoot upset conditions encountered during the manufacturing process and interface with equipment vendors.
  
• Work alongside quality assurance to ensure compliant execution in a regulated GMP space.
  
• Work with business line partners to coordinate and resolve facility issues.
  
• Maintain good organization and communication skills (both oral and written) to regularly report out on projects and work being performed.
  

Other duties include, but are not limited to:

• Provide support for preventative maintenance and calibration.
  
• Provide support for audit and compliance activities.
  
• Provide support for safety assessment and safety related activities.
  
• Maintain training status.
  

Qualifications

Must-Have

• Bachelor's degree with +5 years of pharmaceutical industry experience in a GxP setting or Master's degree with +3 years of relevant experience.
  
• Excellent communication and organizational skills.
  
• Ability to manage projects independently and in partnership with others in cross-functional teams.
  
• Experience with predictive/preventative maintenance programs.
  
• Experience in system lifecycle and equipment validation.
  
• Experience evaluating and interpreting piping and instrumentation diagrams (P&ID), electrical and mechanical drawings (M&E), and computer aided design files (CAD).
  
• Experience working in various business enterprise systems and learning new software packages.
  

Nice-to-Have

• Bachelor's degree or Master's degree in a STEM field (Science, Technology, Engineering, and Math).
  
• Experience in solid dose manufacturing.
  
• Experience with high purity water systems.
  
• Experience with system automation.
  
• An understanding of system and software architecture.
  
• Experience in Spotfire or data visualization software.
  

PHYSICAL/MENTAL REQUIREMENTS

• Role requires Groton CT site presence (not remote).
  
• Standing, walking, bending, climbing, reaching and lifting (up to 55lbs) may be required. Personal Protective Equipment such as gloves, a full Tyvek suit and breathable air or filtering face piece may be required.
  
• The job requires the ability assemble and operate manufacturing equipment.
  

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

• Support of off-shift and weekend manufacturing may be required.
  
• The job may require up to 10% travel for training, factory acceptance testing, or business trips.
  

Other Job Details:

• Last Date to Apply for Job: March 28, 2024
  
• Work Location Assignment: On Premise

  On Premise colleagues work in a Pfizer site because it's needed to get their job done. They may have flexibility to work remotely from time to time, but they are primarily on-site.
  

The annual base salary for this position ranges from $78,000.00 to $130,000.00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 10.0% 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.

Engineering