Engineer I, Technical Operations - Process

Pfizer • Rocky Mount, NC

20h • Onsite

About The Position

As an Engineer I, Technical Operations - Process, you will be responsible for validation of product specific manufacturing processes and cleaning processes for product contact parts and equipment within a large manufacturing facility located in North Carolina, USA. You will ensure that manufacturing and cleaning processes are defined and aligned with specifications and monitor the execution of the processes during validation runs. You will collect samples and data to ensure that the defined processes are reliable and result in product meeting all specifications and cleaning processes that eliminate risks of product carryover.

Requirements

• High School Diploma (or Equivalent) and six years of relevant experience OR an associate degree with four years of experience OR A bachelor’s degree with zero to two years of experience.
• Excellent organizational skills, and ability to handle changing deadlines.
• Strong communication with written and verbal skills.
• Working knowledge of Microsoft Office, especially Excel for evaluation of data.
• Candidates must be authorized to be employed in the U.S. by any employer.
• This position requires permanent work authorization in the United States.

Nice To Haves

• Technical writing experience.
• Experience with pharmaceutical industry validation/qualification of pharmaceutical processes, equipment, utilities, facilities and/or computer systems as related to sterile products and medical devices.
• Working knowledge of Food and Drug Administration (FDA) Regulations/Guidance, and Good Manufacturing Practices (GMP).
• Ability to work both independently and in partnership with others; proven ability to use initiative and drive to achieve results.
• Experience working with process and/or cleaning validation is preferred.

Responsibilities

• Develop and design validation studies, draft study protocols, and confirm validation pre-requisites are met and supported by approved documentation.
• Execute multiple large and small-scale projects while coordinating and communicating all testing with affected functional groups and evaluating test results.
• Provide support and assistance to team members and contractor resources with assigned projects, including support for document data review, peer reviews, and coordinating execution activities.
• Confirm validation documentation adheres to cGDP procedures and industry standards and provide technical expertise to define approaches and support execution of process and cleaning validation activities in alignment with cGMP, cGXP, applicable regulations, procedures, and industry guidance.
• Coordinate and oversee the development of new processes or troubleshoot existing processes in cooperation with cross-functional subject matter experts.
• Participate in and present data, including but not limited to regulatory agency, customer, corporate, or internal requests.
• Provide validation input in risk assessments, validation deviations, and/or quality deviation investigations to identify root causes and define correction and/or preventive actions (CAPA), and author and/or review risk assessment documents that support processes to be validated.
• Participating in teams assembled to complete change control implementation for new equipment and/or products introduced to the facility and participate in developments/improvements to validation programs as needed to remain current with cGMPs and industry standards

Benefits

• 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
• Health benefits to include medical, prescription drug, dental and vision coverage
• Relocation assistance may be available based on business needs and/or eligibility.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level