Manufacturing Specialist (Irvine)

Job Title Scientist

Duration: 6 months + with possible extension

Site: Irvine, CA

1. Ability to understand, set up, and operate moderately complex automated fill/finish equipment for production of prefilled syringes.

2. With minimal supervision, familiarity with setting up and performing laboratory processes. Use of equipment including mixing vessels, filters, tanks, and associated utilities and connections.

3. Ability to document information using good laboratory/manufacturing processes (GLP/GMP) in electronic systems, with excellent writing proficiency.

4. Excellent communication skills, ability to work within a team setting, and follow strict adherence to quality requirements.

5. Basic understanding of Microsoft office tools, and ability to independently draft technical documents.

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.

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.

Basic 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.

Preferred Qualifications:

• Experience in a regulated manufacturing or laboratory environment.

• Familiarity with sterile processing or fill/finish operations.

EEO:

“Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of – Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.”