Senior Process Engineer
Denali Therapeutics
2 hours ago
On-site
Salt Lake City, UT
Operations
Key Accountabilities / Core Job Responsibilities
- Lead production equipment procurement efforts, from vendor selection through installation and qualification, in alignment with FDA GMP requirements.
- Manage Engineering Change Orders (ECOs), ensuring thorough review, proper documentation, and timely implementation of equipment-related modifications.
- Maintain accurate equipment master data, updating technical specifications and operational details for compliance and audit readiness.
- Evaluate and define suitable spare parts substitutes, minimizing equipment downtime and optimizing inventory management.
- Lead site upgrades and buildout activities, collaborating with internal cross-functional teams and contractors to ensure minimal operational disruption and adherence to GMP regulations.
- Develop equipment modification designs, partnering with suppliers and internal stakeholders to enhance process efficiency and product quality.
- Revise P&IDs and equipment drawings, maintaining accurate documentation that reflects current operating conditions and regulatory requirements.
- Conduct risk assessments and gap analyses on new or modified equipment, recommending mitigation strategies that uphold product integrity.
- Provide expert guidance and training to cross-functional teams to drive continuous improvement and robust engineering practices in a GMP environment.
Qualifications / Skills
- Bachelor’s degree or advanced degree in Engineering or an appropriate technical discipline.
- 8+ years engineering experience with a Bachelor’s; 6+ years with a Master’s; or 3+ years with a PhD.
- BioPharm industry experience preferred.
- Ability to travel up to 10% by air and road.
- Demonstrated experience collaborating within technical teams.
- Strong influencing, partnership, and collaboration skills.
- Excellent oral presentation and written communication skills.
- Physical requirements: must be able to put on specialized gowning, lift and manipulate items over 25 lbs, climb ladders, and stand for multiple hours at a time.
Benefits
- 401k, healthcare coverage, ESPP, and a broad range of other benefits.
- Lead production equipment procurement efforts, from vendor selection through installation and qualification, in alignment with FDA GMP requirements.
- Manage Engineering Change Orders (ECOs), ensuring thorough review, proper documentation, and timely implementation of equipment-related modifications.
- Maintain accurate equipment master data, updating technical specifications and operational details for compliance and audit readiness.
- Evaluate and define suitable spare parts substitutes, minimizing equipment downtime and optimizing inventory management.
- Lead site upgrades and buildout activities, collaborating with internal cross-functional teams and contractors to ensure minimal operational disruption and adherence to GMP regulations.
- Develop equipment modification designs, partnering with suppliers and internal stakeholders to enhance process efficiency and product quality.
- Revise P&IDs and equipment drawings, maintaining accurate documentation that reflects current operating conditions and regulatory requirements.
- Conduct risk assessments and gap analyses on new or modified equipment, recommending mitigation strategies that uphold product integrity.
- Provide expert guidance and training to cross-functional teams to drive continuous improvement and robust engineering practices in a GMP environment.
Qualifications / Skills
- Bachelor’s degree or advanced degree in Engineering or an appropriate technical discipline.
- 8+ years engineering experience with a Bachelor’s; 6+ years with a Master’s; or 3+ years with a PhD.
- BioPharm industry experience preferred.
- Ability to travel up to 10% by air and road.
- Demonstrated experience collaborating within technical teams.
- Strong influencing, partnership, and collaboration skills.
- Excellent oral presentation and written communication skills.
- Physical requirements: must be able to put on specialized gowning, lift and manipulate items over 25 lbs, climb ladders, and stand for multiple hours at a time.
Benefits
- 401k, healthcare coverage, ESPP, and a broad range of other benefits.