04 Jan, 2021

Production Process Engineer

  • Pfizer
  • Andover, MA, USA
Process Engineer   Biochemicals / Pharmaceuticals Chemicals

Job Description

Why Patients Need You

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

Working with Pfizer’s dynamic engineering team, you will play a critical role in developing and modifying process formulations, methods and controls to meet desired quality standards. Your production engineering skills will help in recommending and implementing improvements, modifications or additions that will help in solving problems. You will review product requirements in terms of product development compatibility and help Pfizer determine optimum costs and schedules of production.

As an associate, your focus on the job will contribute in achieving project tasks and goals. It is your domain knowledge, commitment, collaboration and dedication that will help us achieve new milestones and patients across the globe.

 

How You Will Achieve It

 

Role Description

Provide engineering and technical support related to the operation, maintenance, installation, startup/commissioning, testing, and qualification of process and automated equipment and systems within a biopharmaceutical manufacturing facility.  This may include production equipment such as bioreactors, fermenters, ultrafiltration skids, Clean – In – Place (CIP) skids, and other support equipment.

 

Role Responsibilities
- Support the operation and troubleshooting of manufacturing equipment and control systems used in the manufacture of biopharmaceuticals

- Support tech transfer and changeover for commercial and clinical processes
- Support reliability engineering for production and support equipment
- Provide on the floor operational support as needed
- Support the design and qualification of improvements, changes, or upgrades to this equipment as needed
- Support the development of design and startup documents such as commissioning plans, User Requirement Specification (URS), Functional Requirement Specification (FRS), Configuration Specification (CS)

- Support the development of validation and qualification documents
- Ensure integrity and compliance of data according to Standard Operating Procedures.
- Provide the execution of commissioning and qualification activities
- Support the maintenance department as needed
- Provide equipment maintenance history review
- Support all investigations and audits as needed
- Support component, equipment, and process improvement projects as needed
- Provide basic automation troubleshooting and support
- Implement PLC, HMI, and database configuration changes
- Provide off-shift and on call support when necessary


Basic Qualifications

- Bachelor's Degree in engineering or similar discipline, or Associate's degree in engineering or similar discipline with prior engineering experience of a minimum 2 years of Pharma engineering experience is required.

- Candidate must be able to work across functional areas such as operations, maintenance, quality and/or regulatory.
- Good communication skills, verbal and written, are required.
- Knowledge of working with computers and associated applications such as MS Word, Excel, and PowerPoint is required.
- Ability to solve complex problems
- Ability to locate information and utilize available organizational knowledge to develop innovative solutions

Preferred Qualifications

- Demonstrated experience in a relevant manufacturing environment
- Knowledge and experience with Drug Product processing and equipment
- Knowledge of database applications and Delta V, Allen-Bradley PLC, GE iFix and iHistorian is preferred
- Technical writing and document review is preferred
- Familiarity of automation network, such as Ethernet, DH+, ControlNet, etc is preferred.
- Knowledge of AutoCAD is preferred

 

 

PHYSICAL/MENTAL REQUIREMENTS

 

Candidate must be able to access clean room environments requiring clean room gowning (donning plant uniforms and coveralls).

 

Candidate must be able to access mechanical spaces that require ascending/descending stairs and or ladders.

Candidate may be required to access confined spaces such as production vessels.

 

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

 

  • Last Date to Apply for Job: 1/7/202
  • Eligible for Employee Referral Bonus

 

 

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.


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