Scientist I

Spectraforce Technologies, Inc.; Irvine (CA); On-site; USD 60,000 - 95,000; Full time

Job summary

Spectraforce Technologies, Inc. in Irvine, CA is seeking a Scientist I to support the U.S. Parenterals and Drug Product Team.

The role involves assisting with setup, operation, and documentation of automated fill/finish equipment for prefilled syringes in a regulated environment, with minimal supervision onsite. Candidates should have a Bachelor's degree in a relevant field, laboratory experience with automated equipment, and strong writing skills to capture GLP/GMP documentation.

Qualifications

• Bachelor's degree in engineering, pharmaceutical sciences, chemistry, pharmaceutics, or related disciplines.
• Laboratory skills and experience with automated equipment.
• Scientific problem solving, experimental design, and trouble shooting skills.
• Experience in a regulated manufacturing or laboratory environment.
• Familiarity with sterile processing or fill/finish operations.
• Ability to document information using GLP/GMP in electronic systems with good writing proficiency.
• Excellent communication skills and teamwork.
• Basic MS Office skills and ability to draft technical documents.

Responsibilities

• Understand, set up, and operate moderately complex automated fill/finish equipment for prefilled syringe production.
• Set up and perform routine laboratory and manufacturing processes with minimal supervision.
• Work with equipment and systems including mixing vessels, filters, tanks, and associated utilities and connections.
• Accurately document activities and results in electronic systems in accordance with GLP/GMP requirements.
• Independently draft clear and accurate technical documents as needed.
• Excellent communication skills, ability to work within a team setting, and follow strict adherence to quality requirements.
• Use Microsoft Office tools to support documentation and reporting tasks.

Skills

Bachelor's degree

Laboratory experience

Automated equipment

GLP/GMP documentation

Regulated environment

Sterile processing

Technical writing

Microsoft Office

Teamwork

Troubleshooting

Education

Bachelor's degree in engineering, pharmaceutical sciences, chemistry, pharmaceutics, or related disciplines

Job description

Position Title: Scientist I

Work Location: Irvine, CA, USA 92612

Assignment Duration: 3+ Months

Work Arrangement: Onsite

Position Summary:

The U.S. Parenterals and Drug Product Team within Process Development, Science, and Technology (PDS&T) is a global organization that supports drug product process development, commercial site scale up, and tech transfer. The candidate will support manufacturing and laboratory operations in a regulated environment. This role is responsible for assisting with the setup, operation, and documentation of moderately complex automated fill/finish equipment used in the production of prefilled syringes, as well as performing routine laboratory and manufacturing processes under minimal supervision. The ideal candidate will demonstrate strong attention to detail, clear communication skills, and a commitment to quality, compliance, and teamwork.

Key Responsibilities:

• Understand, set up, and operate moderately complex automated fill/finish equipment for prefilled syringe production.
• Set up and perform routine laboratory and manufacturing processes with minimal supervision.
• Work with equipment and systems including mixing vessels, filters, tanks, and associated utilities and connections.
• Accurately document activities and results in electronic systems in accordance with GLP/GMP requirements.
• Independently draft clear and accurate technical documents as needed.
• Excellent communication skills, ability to work within a team setting, and follow strict adherence to quality requirements.
• Use Microsoft Office tools to support documentation and reporting tasks.

Qualifications & Experience:

• Bachelor's degree in engineering, pharmaceutical sciences, chemistry, pharmaceutics, or related disciplines.
• Laboratory skills and experience with automated equipment.
• Scientific problem solving, experimental design, and trouble shooting skills.
• Experience in a regulated manufacturing or laboratory environment.
• Familiarity with sterile processing or fill/finish operations.
• Ability to understand, set up, and operate moderately complex automated fill/finish equipment for production of prefilled syringes.
• With minimal supervision, familiarity with setting up and performing laboratory processes. Use of equipment including mixing vessels, filters, tanks, and associated utilities and connections.
• Ability to document information, e.g., from syringe measurements, using good laboratory/manufacturing processes (GLP/GMP) in electronic systems, with excellent writing proficiency.
• Excellent communication skills, ability to work within a team setting, and follow strict adherence to quality requirements.
• Basic understanding of Microsoft office tools, and ability to independently draft technical documents.