Process Engineer

Category:

Life Science

Employment Type:

Direct Hire

Reference:

BH-381494

Yoh is seeking a Process Engineer for our Pharmaceutical client in Noblesville, Indiana. This is a growing company with a growing team.

Summary of Position

The Senior Process Engineer will be a key contributor in a dynamic organization. The role will implement new product projects in support of Curium's growth strategy in radiopharmaceutical therapeutic sterile drug products. Projects can include technical transfer, new and generic drug development, conceptual design, scoping and estimation, integration, etc. The Senior Process Engineer will work collaboratively in a cross-functional organization with R&D, Project Management Organization, Quality Assurance, Quality Control, Validation, and Manufacturing through all phases of projects from concept evaluation through commercial product launch.

Work Schedule: Monday - Friday 8:00am - 5:00pm. Hours could be adjusted.

Essential Functions

• Support cross-functional projects and project teams through process evaluation, design, and implementation of robust processes for new products within existing or new manufacturing equipment.
• Write technical documentation (protocols & reports for equipment/instrument qualifications, comparability, process, and manufacturing process validation testing)??
• Involvement in product launch activities preferred.
• Work collaboratively to quickly move projects from scoping to implementation.
• Provide Aseptic Manufacturing experience and guidance of evaluation and design of new processes.
• Partner with Quality to ensure good quality and cGMP practices and their implementation in new product launch.
• Provide input to forecast estimates for project related costs and general project task tracking for adherence to project milestone goals.
• Must maintain operational compliance with US and international requlatory agencies and guidelines (i.e. FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.).

• Bachelor Degree in Chemical Engineering preferred or related field such as Bioengineering, Chemistry, and Biotech.
• Five years or more of relevant experience while working in cGMP manufacturing environments. Significant experience in optimization of processes, including establishment of process KPI's.
• Experience in pharmaceuticals desired, however willing to consider other development areas such as medical devices experience.
• Experience with medical isotopes preferred.
• Strong project management and organizational skills, including ability to work independently as a team member.
• Knowledge of aseptic technique, regulatory requirements, and validation activities needed for manufacturing parenteral products preferred.
• Experience leading formal Root Cause Analysis and problem-solving methodologies.
• Technical understanding of the pharmaceutical development process from concept to launch.
• Proven collaborative experience within complex multi-discipline project teams in a highly regulated environment.
• Strong oral and written communication skills with proven ability to communicate effectively at all levels in high pressure environments.
• Agile approach and willingness to learn new things - ability to work "on the fly" in a dynamic setting.
• Intermittent travel may be required up to 10% of the time.
• Lean and/or Six Sigma certification preferred.