Process Engineer, II (Cell Therapy CDMO)

Job Summary

Cellipont Bioservices is growing, and we are looking for a Process Engineer, II who believes in the potential of bridging client's discoveries to patient cures and who want to challenge the status quo and take Cellipont and its clients to the next level.

The Process Engineer II is responsible for supporting the development of scope, client interface, cost and schedule development, project reporting, scheduling and execution, and validation interfaces for process equipment and other related projects as assigned. The process engineer serves as the Subject Matter Expert in a specific technical area with responsibilities to train and support users, troubleshoot, and resolve operational problems.

The Role

• Evaluating processes and equipment to ensure compliance with environmental and safety regulations.
• Ability to populate an IQ/OQ/PO Validation Protocol.
• Development of documentation to show and ensure compliance with both internal and external regulations and protocols
• Assist with management of equipment maintenance activities, including preventative maintenance and calibration activities.
• Equipment troubleshooting and repairs as necessary.
• Assist with the setup, coordination, implementation and tracking of preventative maintenance and calibration programs.
• Identify and manage inventory of critical equipment and spares.
• Oversee projects in a PM role. Mange timeline and costs with approved budgets.
• Monitor and manage equipment lifecycle.
• Performs other duties as assigned
• Must be able to work and be on call on off day shifts including weekends
  
  

The Candidate

• Bachelor's Degree in Engineering (or similar discipline) with minimum of 2 years of direct experience in maintenance, operations, or engineering of GMP and Non-GMP production and facility equipment and systems in manufacturing plant.
• The ability to work and lead a team without constant oversite.
• Impromptu decision making and critical thinking in emergency situations where guidance is unavailable.
• Good writing and communication skills.
• Knowledge of troubleshooting mechanical, pneumatic, and refrigeration systems.
• Knowledge on CAD, Visio, and Microsoft office products.
• Experience with CMMS and CMS software.
• Understanding of validation requirements as defined in the CFR.
• Possess excellent interpersonal skills, both written and oral.
• Requires knowledge of instrumentation calibration.
  
  

Work Environment

• Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities
• Ability to work off-shift and extra hours as required
• Weekends & Holidays as required
  
  

Position Benefits

• Opportunities for career growth within an expanding team
• Defined career path and annual performance review & feedback process
• Cross-functional exposure to other areas of within the organization
• Robust benefit package designed for unique Health & Wellness needs, including coverage for your furry family members
• 401K strong employer match
• Tuition Reimbursement
• Employee Referral Bonuses
• Flexible work schedules and PTO based on role/level, increasing 1 PTO day each year and paid holidays
• Gain experience in the cutting-edge cell therapy space
  
  

"At Cellipont Bioservices, we look for candidates with an innate desire to serve. Our "family" approach ensures you will get the mentorship you need to develop a satisfying career here!"

Notice to Agency and Search Firm Representatives

Cellipont Bioservices is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Cellipont Bioservices employee by a third-party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Cellipont Bioservices. No fee will be paid if a candidate is hired for this position because of an unsolicited agency or search firm referral. Thank you.