**EASY APPLY on our Company Page with RESUME ONLY (Cover page optional).
We are seeking a qualified Process Engineer to work within the BioProcess Development Department.
Core Responsibilities
- Execute concurrent projects of moderate scope and complexity, with minimal supervision.
- Interpret and execute policies and procedures. Recommend modifications to operating policies.
- Function as a technical expert on equipment or systems (RSE); lead troubleshooting of operations, develop preventative maintenance procedures, and maintain engineering documentation.
- Lead efforts with manufacturing, process development, facilities, quality assurance and other departments in developing requirements and recommendations for system modifications.
- Execute tasks, under the direction of project managers, to complete design, engineering, construction, commissioning, and qualification for projects within schedule and budget constraints.
- Coordinate the work of consultants and engineering firms on development of standard design documents.
- Develop project scopes, schedules and budgets.
- Obtain and critique quotes for system/facility modifications and work with vendors to execute.
Skills:
- General understanding of Quality Systems.
- General understanding and wide application of technical principle, theories, and concepts in the Biotech/Pharmaceutical field.
- General knowledge of other related disciplines.
- Demonstrated skills in the following areas:
- Problem solving and applied engineering
- Basic technical report writing
- Communication
- Working knowledge of pharmaceutical/biotech process
- Experience in Bio-Pharmaceuticals Direct experience with regulated environments (i.e. cGMP, OSHA, EPA).
- Working knowledge of specialized equipment/processes.
- General knowledge of Commissioning and Qualification.
- Effectively interact with a variety of communication and working styles.
- Ability to independently determine when additional internal/external resources are required to solve problems.
Education:
- BS in Mechanical or Chemical Engineering with 3-6 years experience in pharmaceutical/biopharmaceutical industry or related industry/cGMP environment.
- Based on level, should have demonstrated experience with manufacturing processes and equipment such as CIP systems, bioreactors, filtration skids, chromatography and lyophilization equipment, etc.
Required Skills:
CGMP
ENGINEER
PHARMACEUTICAL/BIOTECH
ENGINEERING DOCUMENTATION
Additional Skills:
EPA
FILTRATION
LYOPHILIZATION
MANUFACTURING PROCESSES
PROBLEM SOLVING
PROCESS ENGINEER
REPORT WRITING
TECHNICAL REPORT WRITING
BIOPHARMACEUTICAL
BIOTECH/PHARMACEUTICAL
BUDGETS
DOCUMENTATION
MAINTENANCE
OPERATIONS
PROCESS DEVELOPMENT
About us:
We are not a large corporate consulting conglomerate, we are a small and steadily growing valuable consulting firm. -Valuable to our clients and consultants we work with. We have an excellent reputation with our clients and one that we continue to build upon. We are always looking for top talent.
**EASY APPLY on our Company Page with RESUME ONLY (Cover page optional).