What are the responsibilities and job description for the Process Engineer position at The Fountain Group?
Our breakthroughs would not make it to the hands of patients without our pharmaceutical manufacturing team. We rely on a team of dedicated and agile members, who understand the importance and impact of their role in Pharmaceutical’s mission. Patients need colleagues like you who take pride in their work and always look to improve outcomes. You will help to ensure that patients and physicians have the medicines they need, when they need them.
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, Pharmaceutical Values, and global regulatory guidelines, environmental guidelines etc.
Responsibilities:
- 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.
- Participate and drive in continuous improvement and innovation initiatives.
- 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.
Qualifications:
- Bachelor's Degree in Science or Engineering and 2 years of experience within the pharmaceutical industry
- Mechanical knowledge and the use of hand tools
- Effective verbal and written communication skills
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
