Hovione is an international company with over 55 years’ experience in the development and compliant manufacture of Active Pharmaceutical Ingredients and Drug Product Intermediates. With four FDA inspected sites in Portugal, the U.S., Ireland and China, Hovione offers integrated API, particle design, formulation development and GMP manufacturing. In the inhalation area, Hovione is the only independent company offering such a broad range of services.
Hovione is making a definite move into Continuous Manufacturing with a state-of-the-art facility in New Jersey and is now hiring. We are looking for strong professionals for this exciting and innovative project. We are recruiting for the following position at our U.S. site located in East Windsor, NJ:
Process Engineer - Drug Product Continuous Manufacturing
The Process Engineer will ensure support of development and commercial manufacturing activities for the drug product continuous manufacturing area, in order to achieve clients’ expectations and Hovione objectives in compliance with all Federal, State and Local requirements, namely: EPA, OSHA and FDA, and with all Hovione internal policies. The Process Engineer will be responsible for meeting project timelines, product quality, required yields and project budget, and to guarantee that operations are executed according to cGMP rules.
- Plans and executes manufacturing processes to run safely and effectively in a drug product facility in accordance with best known practices ensuring cGMP compliance.
- Contributes to the Process Hazard Analysis (PHA) of all processes under his/her responsibility and assures that all identified hazards are addressed prior to performing any activities within operations.
- Plans and implements methodologies to improve efficiency in production.
- Participates in all necessary HSE training (i.e. hazardous waste management) and monthly meetings.
- Maintains an open communication with other employees and management concerning HSE topics, including documentation of incidents and/or issues.
- Prepares mass balance sheet, instructions for unit operations, production batch records, Bill of Materials, cleaning protocols, and other GMP-related documentation for all processes run in operations. Participates in the scale-up runs in the R&D laboratory.
- Prepares scientifically sound reports (campaign, monthly, deviation investigation, others) in a timely manner.
- Trains operations personnel on the use of production systems and procedures.
- Assists in the preparation of technology transfer packages and technology transfers of processes/products either to Hovione or clients facilities.
- Degree in Chemical Engineering and a minimum of 1 year of industrial experience in either chemical or pharmaceutical environment, preferentially within a FDA regulated manufacturing facility performing the various aspects of the Process Engineering role.
- Working knowledge of cGMPs as per Eudralex and CFR21 parts 210 to 211.
- Result driven, team player and able to deal with multiple projects/tasks
- Good team management and communication skills
- Creative, problem solver, organized
- Good capacity for planning, execution and coordination
- High sense of responsibility
- Ability to work under pressure
- Passion for science and innovation
- Fluent in English, excellent written and verbal communication skills
- Creativity, organization and discipline