What are the responsibilities and job description for the Process Engineer position at I3 INFOTEK INC?
Title: Process Engineer
Location: Andover, Massachusetts, United States
Key Aspects:
This role involves overseeing and executing process and equipment operations during manufacturing, ensuring compliance with Good Manufacturing Practices (GMP), and contributing to project milestones and continuous improvement initiatives.
What You Will Achieve
You will have knowledge of process equipment and systems and manufacturing operations with the primary responsibility to execute process and equipment operation activities during manufacturing operations. Due to your expertise in the manufacturing domain, you may participate in training for operational qualifications and assist the Team Lead or other team members as needed. You will conduct all activities in accordance with Company policies and standard operating procedures, Pfizer Values, and global regulatory guidelines, environmental guidelines etc.
As an associate, your focus on the job will contribute in achieving project tasks and goals. Through your domain knowledge and commitment, you will create a collaborative team environment for your colleagues.
It is your hard work and focus that will make Pfizer ready to achieve new milestones and help patients across the globe.
How You Will Achieve It
• Contribute to completion of project milestones and organize own work to meet project task deadlines.
• Use operational and technical expertise to assist in troubleshooting activities, technology transfer and start-up activities.
• Monitor the technical documentation for the production and processes approval.
• Ensure all production equipment and systems are in compliance with {Current} Good Manufacturing Practices.
• Manage execution of relevant process activities by following established Standard Operating Procedures.
• Perform process monitoring and data analysis, and data preparation for presentation in several forums including project team meetings.
ROLE RESPONSIBILITIES
Capable of managing inter-departmental projects and performing relevant presentations.
• Individual will provide subject matter expertise in supporting process and author product related investigations, execute CAPAs, and provide impact assessment to moderately complex process and equipment change controls to ensure a robust and capable solution.
• Individual will be expected to participate and drive in continuous improvement and innovation initiatives. Individual is expected to be an M1 lead.
• Individuals will be required to display multi-tasking skills.
Qualifications
Must-Have
• 2 Bachelor's Degree
• Experience within the pharmaceutical industry
• Effective verbal and written communication skills
• Mechanical knowledge and the use of hand tools
Nice-to-Have
• Master’s Degree
• Demonstrated ability to train and coach others
• Experience with Six Sigma or other operational excellence programs
• In-depth knowledge of drug substance/drug substance intermediate manufacturing technology
PHYSICAL/MENTAL REQUIREMENTS
• Daily routine may require moving heavy equipment, standing for long periods of time, and/or walking throughout the suite including up and down stairs.
• Must have the ability to lift ~50 pounds.
• The incumbent needs to take the necessary safety precautions when working with pressurized systems, steam and/or corrosive chemicals.
• The incumbent is required to attain detail knowledge of the operational equipment.
• The incumbent will be required to solve problems regarding site assessment, specific units used in Biopharmaceutical manufacturing.
- • The incumbent must be able to express ideas into SOPs, MFRs and be able to use a multitude of programs including Excel, Word, Power Point, etc.