Process Engineer II

job summary:
Are you a hands-on engineering professional ready to make a direct impact on the manufacturing floor? A Top-Tier Molecular Diagnostics & Life Sciences Leader in beautiful Carlsbad, CA is seeking a permanent, on-site Process Engineer II . Reporting to the Director of Technical Operations, you will lead reagent formulation, filling, and finishing activities, working closely with floor technicians to ensure peak operational excellence.

This role is an on-site position Monday - Friday 8 hours/day (excluding lunch break). Overtime, weekends and holidays may be required. Flexible start time between 7:00 am - 9:00 am with a consistent schedule.

location: Carlsbad, California
job type: Permanent
salary: $95,000 - 105,000 per year
work hours: 9 to 5
education: Bachelors

responsibilities:

• Develop and validate QC and manufacturing methods, including executing IQ/OQ/PQ for laboratory equipment.
• Lead quality investigations such as deviations, CAPAs, NCMRs, and OOS/OOT issues.
• Direct the transfer of New Product Introductions (NPIs) from development to the manufacturing shop floor.
• Design and execute experimental protocols, interpret data, and author technical documents (SOPs, master batch records).
• Troubleshoot existing processes and collaborate cross-functionally to drive continuous improvement.

 
qualifications:

Required:

• Bachelor's degree in Biology, Engineering, Computer Science, or a related scientific field.
• 4+ years of experience in an industrial manufacturing environment.
• Proven knowledge of ISO 13485 Quality Management Systems and GMP standards.
• Strong understanding of LEAN practices and continuous improvement tools (Kaizen, DMAIC, FMEA).

Preferred:

• Experience in organic chemistry, chromatography (HPLC/UPLC), and cleanroom manufacturing.
• Familiarity with statistical process control and DOE techniques.

#LI-AO1

skills: Chromatography, Ultra Performance Liquid Chromatography (UPLC), High Pressure Liquid Chromatography (HPLC), Good Manufacturing Practices (GMP), Corrective and Preventive Actions (CAPA)


Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact View email address on randstadusa.com.


Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).


This posting is open for thirty (30) days.

Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.


Qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.


We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.