Process Engineer

Kinovate Life Sciences, Inc. established in 2004 in Oceanside, California. A wholly owned subsidiary of Nitto Denko Corporation (www.nitto.com), Kinovate was spun-off from Oceanside, CA based R&D facility Nitto Denko Technical Corp (www.ndtcorp.com) with a mission to provide the highest quality materials to niche life science markets worldwide.

Since its inception, Kinovate has grown to become the market leader in solid support in the oligonucleotide synthesis field. We are bringing the most creative minds in science and technology to develop medical discoveries and breakthroughs. Our customers are well-known in the biotechnology industry. We are in a growth phase within ISO work environment and leading towards a GMP Certification. KLS is seeking extraordinary people to join the team. KLS is proud to be an equal employment opportunity employer.

Why Work Here Great place to work. Small subsidiary of large international company headquartered in Japan. Generous discretionary bonuses. Health, dental, vision, life, and disability insurance effective from date of hire. Additional benefits include 401(k), 3 weeks vacation in your first year, 12 paid yearly holidays, 5 paid sick days, tuition reimbursement and more.

JOB SUMMARY:

Under general guidance, lead process design modifications and evaluate manufacturing techniques to improve safety, efficiency and quality. Create, review, and analyze process layouts, equipment specifications, and engineering drawings. Design, specify, and procure the necessary equipment to support production and upgrades to the shop floor to increase production capacity and capability. Collaborate cross-functionally on production data analysis and implement process improvements within a Current Good Manufacturing Practices (cGMP) and International Organization for Standardization (ISO) environment.

ESSENTIAL DUTIES and/or RESPONSIBILITIES:

1. Design, modify, and continuously improve production processes and equipment using established engineering standards, historical data, and best practices. Collaborate with engineering peers, equipment vendors, and suppliers to ensure process designs meet functional, safety, and capacity requirements; utilize CAD tools as needed to support layouts, and equipment modifications.

2. Ensures existing or new process development or redesign projects are completed in accordance with Quality System requirements. Participate in and lead design reviews.

3. Develop experimental tests to ensure processes and components meet performance, quality, and reliability requirements for intended use.

4. Prepare and maintain comprehensive engineering documentation, including process flow diagrams, piping and instrumentation diagrams (P&IDs), standard operation procedures (SOPs), equipment specifications and process information.

5. Collaborate cross‑functionally with internal teams to support scale‑up from R&D through commercial production, ensuring smooth technology transfer and stable manufacturing performance.

6. Analyze production and process data to identify inefficiencies, root causes, and continuous improvement opportunities; implement process optimization initiatives to improve throughput, yield, cost, and overall equipment effectiveness (OEE).

7. Provide technical support to internal teams, including participation in risk assessments, hazard analyses, and responses to regulatory inquiries (local, state, federal, and international). Support training of site personnel on new processes, equipment, and operational changes.

8. Identify, assess, and mitigate EHS and quality risks using Risk Assessment methodologies.

9. Other duties as assigned.

MINIMUM EDUCATION and/or EXPERIENCE:

1. Bachelor’s degree in Chemical, Mechanical, Industrial or Manufacturing Engineering or related field; and four (4) to six (6) year’s directly related experience or equivalent combination of education and experience.

2. Experience working in cross‑functional teams and interfacing with operations, quality, R&D, EHS, and external vendors.

KNOWLEDGE, SKILLS and/or ABILITIES:

1. Intermediate knowledge of chemical, electrical, mechanical, manufacturing processes and trouble-shooting methods and techniques. Ability to size and select chemical process equipment.

2. Working knowledge in reading and commenting P&ID, PFD, and other technical drawings.

3. Work independently and foster a cooperative spirit within a large and/or small team.

4. Working knowledge of process hazard analysis and other risk assessment techniques.

5. Ability to work in a detailed-oriented environment with basic follow-up and organizational ability.

6. Strong application of critical thinking skills along with exceptional problem-solving skills.

7. Strong multi-tasking skills, flexibility in responding to rapidly changing, dynamic processes and demands/pressures in a fast-paced environment.

8. Ability to read and interpret documents such as safety rules, operating and maintenance instructions and procedure manuals. Effectively present information in one-on-one and small group situations for customers, clients, and other employees across functional groups/matrix format.

9. Write clear processes, manuals and reports for management review and present technical information in understandable terms and respond to questions from groups of customers, employees and/or public.

10. Work with mathematical concepts such as probability and statistical inference and fundamentals of plane and solid geometry and trigonometry.

11. Deal with practical problems and/or issues involving a variety of concrete variables in situations where limited standardization exists.

12. Intermediate working knowledge of Microsoft Office Suite and CAD software.

PHYSICAL DEMANDS and/or WORK ENVIRONMENT: (Typical physical demands and the work environment characteristics an employee must meet and encounter while performing the essential functions of the job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.)

1. Ability to work at a desk for extended periods of time.

2. Ability to stand and walk around the facilities for extended periods of time.

3. Perform walkthrough inspections of all facilities (both inside and outside plants) which require exposure to varying temperatures, noise levels above 80 decibels and use of personal protective equipment in certain areas.

4. Attend meetings off-site.

5. Must be able to work extended hours per the demands of the business.

6. Must be able to lift to 50 pounds.