Bio-Manufacturing Process Engineer III

Employer
Arranta Bio
Location
Watertown, MA, United States
Posted
Nov 17, 2020
Ref
85503-313505
Hotbed
Genetown
Required Education
Bachelors Degree
Position Type
Full time
ABOUT US

Arranta Bio is a rapidly growing and dynamic bio-pharmaceutical contract development and manufacturing organization (CDMO). Our vision is to be the best in class CDMO providing development and GMP manufacturing services to microbiome innovators within the pharmaceutical industry. Therapies focused on the human microbiome are exhibiting incredible potential towards revolutionizing disease etiology and associated medical treatments. Arranta Bio's mission is to build a world class organization which provides microbiome bio-pharmaceutical innovators with a single source of supply from early process development through clinical and commercial GMP finished product.

WHO ARE WE

Arranta hires people who are committed and passionate to the goal of bringing life enhancing products to patients. We want top talent who will render ideas and a relentless desire towards accomplishing our mission; when a job becomes a passion, it makes you feel ALIVE.

Here at Arranta Bio, we embrace ALIVE - our core values that we live and breathe daily! We are Agile, Leading, Innovating, Value Creating, and Engaging.

We embrace our challenges as opportunities.

We are empowered to think and act.

We never settle; we strive to improve through purposeful creativity.

We build aligned teams who learn, grow, and deliver.

We are committed to building strong relationships.

Are you ready to come ALIVE with a daring and intrepid team? Don't wait another minute; Apply today!

JOB SUMMARY

Arranta Bio seeks Bio-Manufacturing Process Engineer III who brings enthusiasm, intellectual curiosity, scientific rigor, and a desire to help drive novel programs. The candidate must be independent, goal-oriented, flexible, and able to work efficiently across multiple projects. We are searching for enthusiastic, and innovative individuals with a good understanding of Change Controls, Quality Investigations, and familiar with Upstream and Downstream biomanufacturing principles.

ESSENTIAL JOB FUNCTIONS
  • Lead to completion of project milestones and organize own work to meet project task deadlines.
  • Promote Current Good Manufacturing Practices compliance within the workplace by following site cGMP procedures and incorporate cGMP regulatory and safety compliance into all assigned projects scope and design.
  • Collaborate with Process Development groups during the development of new products to provide a commercial operations perspective.
  • 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.
  • Develop and sustain a culture of quality, safety and continuous improvement within the team for effectiveness and efficiency of resource utilization.
  • Effectively maintain good communication and collaborate with cross-functional colleagues and external partners for successful execution/completion of projects.
  • Participate in the tech transfer and scale-up of developed processes to pilot and/or GMP manufacturing.
  • Work on problems of diverse scope (bridging upstream and downstream processes, manufacturing


Experience and Skills

EDUCATION AND/ OR EXPERIENCE
  • 4+ Bachelor's Degree
  • Experience within the pharmaceutical industry
  • Effective verbal and written communication skills
  • Mechanical knowledge and the use of hand tools
  • Demonstrated ability to train and coach others
  • Experience with Six Sigma or other operational excellence programs

PHYSICAL DEMANDS

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
  • The employee is frequently required to stand; sit; use hands to finger, handle, or feel; reach with hands and arms; and talk or hear.
  • The employee is occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl.
  • The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds.
  • Specific vision abilities required by this job include close vision, and ability to adjust focus.