Senior Process Engineer
About The Position
The Senior Process Engineer is responsible for the design, commissioning, and operation of the KKNA Manufacturing Facility, including Tech Transfer, Process Definition, Troubleshooting, and Process Optimization. As an individual contributor, you will take a compassionate and people-focused approach to your work. You will proactively collaborate with others to create a supportive and inclusive environment, always acting in line with the organization’s values. You will work effectively across diverse teams, manage relationships thoughtfully, and make decisions that meet both individual and team needs. You will be accountable for delivering results, adapting to challenges, and helping achieve business goals. Additionally, you will take ownership of your tasks, act with initiative, and continuously seek opportunities to learn and grow. You will handle change with resilience and clarity, staying flexible in a fast-paced environment while keeping the needs of patients at the center of your efforts.
Requirements
- Bachelor’s degree in Chemical Engineering, Mechanical Engineering, Biotechnology Engineering, or a related field
- Minimum 5 years’ experience as a process engineer in Pharma, Biopharma, and/or Life Science industries in a manufacturing/operations role.
- Knowledge and experience of Single Use Technology (SUT), preferably in monoclonal antibody (mAb) processing.
- Knowledge and understanding of Good Manufacturing Practices (GMP) and quality compliance issues related to both clinical and commercial manufacturing.
- Proficiency in Microsoft Office Suite
- Strong troubleshooting and process optimization capabilities
- Experience with change control, documentation, and regulatory compliance
- Strong organizational and time management skills with the ability to meet deadlines
- Excellent written and verbal communication skills
- Strong attention to detail and follow-through
- Ability to work independently and adapt in a dynamic, fast-paced environment
- Demonstrated ability to manage ambiguity and shifting priorities
- Commitment to continuous learning and development
- Ability to build relationships and collaborate across a global organization
Nice To Haves
- Experience with starting up and operating a biopharma manufacturing facility is a plus.
Responsibilities
- Provide hands-on support and guidance for the installation, maintenance, troubleshooting, and repair of assets and systems supporting the manufacturing facility
- Assume system ownership within Upstream Processing, Downstream Processing, or Solution Preparations, maintaining cradle-to-grave accountability from design through operations acceptance
- Draft, review, and approve documentation, including operating procedures, maintenance plans, engineering drawings, and equipment specifications
- Participate in Operational Readiness (OR) planning and execution
- Collaborate with Manufacturing, Manufacturing Sciences, and Automation to evaluate and support new product introductions
- Support preparation of maintenance, calibration, and qualification plans
- Manage technical and engineering changes through the change control process
- Support internal and external audits
- Execute all work in alignment with regulatory requirements
Benefits
- 401K with company matching
- Discretionary Profit Sharing
- Annual Bonus Program (Sales Bonus for Sales Jobs)
- Generous PTO and Holiday Schedule which includes Summer and Winter Shut-Downs, Sick Days and, Volunteer Days
- Healthcare Benefits (Medical, Dental, Prescription Drugs and Vision)
- HSA & FSA Programs
- Well-Being and Work/Life Programs
- Long-Term Incentive Program (subject to job level and performance)
- Life & Disability Insurance
- Concierge Service
- Pet Insurance
- Tuition Assistance
- Employee Referral Awards
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What This Job Offers
Job Type
Full-time
Career Level
Senior
