Clene is revolutionizing the treatment of neurodegenerative disease with an innovative nanotherapeutic platform to generate first-in-class elemental nanomedicines.
We are currently recruiting for an R&D Engineer, who will work as a member of a team of engineers and scientists, as you use engineering principles to implement manufacturing processing in a cGMP environment.
Your responsibilities include:
- Provide operational support, troubleshooting, and optimization for assigned equipment
- Support equipment maintenance activities to improve reliability
- Apply engineering principles to the design and implementation of new equipment
- Identify risks and implement risk reduction strategies
- Lead and execute improvement efforts including cycle time reduction, efficiency gains, and yield enhancement opportunities
- Lead or support technical root cause analysis, incident investigations, and troubleshooting on equipment
- Analyze problems, develop and propose engineering solutions in a scientific manner using data-driven techniques and analyses
- Support new product introductions or new technology introductions by performing engineering assessments, implementing equipment modifications, and supporting engineering runs
- Apply process engineering principles in the design, specification, construction, startup, and validation of process equipment and systems for capital projects of moderate scope and complexity
- Support non-standard shift organization and extended hours, as per business needs
- Bachelors degree and 2 years of Engineering experience
- Masters degree
- Direct experience with regulated environments (e.g. FDA, cGMP, OSHA, EPA, etc.).
- Hands-on experience with manufacturing process equipment including advanced troubleshooting, reliability and performance improvements, and design optimization.
- Working knowledge and experience with cGMP procedures and engineering practices on pharmaceutical/biotech production processes, facilities, and equipment.
- Experience with change control, nonconformance, corrective and preventative actions, and validation practices.
- Experience supporting design and startup engineering directly related to bulk biopharmaceutical production including process equipment and facilities design, procurement, construction, startup, and validation.
Clene Nanomedicine, Inc. provided the following inclusive hiring information:
We are an equal opportunity employer who considers all qualified applicants equally without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.
Job Type: Full-time
Pay: $65,000.00 - $80,000.00 per year
- 401(k) matching
- Dental insurance
- Disability insurance
- Flexible spending account
- Health insurance
- Life insurance
- Paid time off
- Parental leave
- Vision insurance
- 10 hour shift
- 8 hour shift
- Day shift
- Monday to Friday
- Night shift
- Weekend availability
Ability to commute/relocate:
- North East, MD 21901: Reliably commute or planning to relocate before starting work (Preferred)
- Engineering: 2 years (Required)
- Day Shift (Preferred)
- Night Shift (Preferred)
- Overnight Shift (Preferred)
Work Location: One location