Tech Transfer Automation Engineer III

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Job description

ROLE SUMMARYThe Tech Transfer Automation Engineer III will provide automation and technical subject matter expertise related to the evaluation, technology transfer, startup, and qualification of new and existing equipment, facilities, and utilities in support of new product introduction. This may include production equipment such as the Manufacturing Control System, bioreactors, ultrafiltration skids, Clean - In - Place (CIP) skids, and other support equipment and automation system components.

ROLE RESPONSIBILITIES

• Responsible for the introduction of new products into an existing biopharmaceutical facility
• Perform new product facility fit assessments including equipment selection and sizing, utility usage estimates, and automation requirements
• Execute the design and qualification of automation system improvements, changes, or upgrades to this equipment as needed
• Perform planning and scheduling through development of process models and modelling support tools using Schedule Pro
• Develop design and startup documents such as commissioning plans, User Requirement Specification (URS), Functional Requirement Specification (FRS), Configuration Specification (CS)
• Develop validation and qualification plans, protocols, and summary reports
• Perform the execution of commissioning and qualification activities
• Execute component, equipment, and process improvement projects as needed
• Develop tech transfer and product changeover scopes of work and work with planners and schedulers to plan and implement the work
• Develop tech transfer automation scopes of work
• Maintain equipment portfolio and equipment reservation databases
• Implementation of PLC, HMI, and database configuration changes in support of product changeover
• Identify and implement automation improvements to reduce product changeover time in the suite
• Identify and support long term capital projects to improve new product introduction efficiency
• Provide on the floor operational support as needed
• Provide off-shift and on call support when necessary
  

BASIC QUALIFICATIONS

• BS/MS in engineering or relevant discipline is required. Chemical Engineering discipline preferred.
• Minimum of 3 years of experience in this industry is required
• Must be able to work across functional areas such as operations, technical services, maintenance, quality and regulatory.
• Good communication skills, verbal and written, are required.
• Knowledge of computer and automation systems and associated applications such as MS Word, Excel, Visual Basic and PowerPoint is required.
• Ability to solve complex problems
• Ability to locate information and utilize available organizational knowledge to develop innovative solutions
• Knowledge of database applications and Delta V, Allen-Bradley PLC, GE iFix and iHistorian preferred
• Technical writing and document review

PHYSICAL/MENTAL REQUIREMENTS

• Ability to sit, stand, bend, and walk to access equipment in a clean room environment
  

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

• Minimal travel for equipment support
• Ability to work off shift (Nights and Weekends) as needed
• Ability to work in a clean room environment

Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.

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.

Engineering

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