Title:
Process Development Engineer I
Pay:$35.00-$40.75/hr
Location:
San Diego, CA – Onsite
Duration:
13-month contract
Schedule:
8:00 AM–5:00 PM
Overview
This position supports manufacturing project activities, including oligonucleotide production and analysis, process development and transfer, and operational improvements in a regulated manufacturing environment.
Key Responsibilities
- Provide technical guidance in the production and analysis of oligonucleotides in a regulated manufacturing environment.
- Collaborate with cross-functional teams to resolve production issues related to safety, yield, quality, and throughput; develop and transfer new processes and products to production; and enhance existing processes and products.
- Represent and advocate for Operations’ needs in cross-functional meetings to ensure the quality, continuity, and efficiency of products and processes transferred to and implemented within manufacturing teams.
- Apply change management practices to drive improvements in safety, quality, efficiency, and cost.
- Support the transfer of manufacturing processes between manufacturing locations.
- Maintain productive cross-site and cross-functional relationships.
- Execute manufacturing builds as needed to support development, pre-production, and production orders.
- Plan and prioritize assigned tasks and activities with minimal guidance.
- Execute tasks independently, with guidance from the project lead or manager as needed.
- Influence technical decisions within the assigned area of responsibility.
- Track component cost of goods sold (COGS) and associated project expenses.
Qualifications
- Manufacturing experience in organic synthesis is highly desirable.
- Working knowledge and experience with automated synthesis and preparative and analytical chromatography.
- Experience with LC-MS and the ability to interpret NMR data are desirable.
- Experience in process support and development within a GMP environment.
- Strong understanding of GMP and experience with standard laboratory practices.
- Strong analytical, problem-solving, troubleshooting, and root cause analysis skills.
- Strong interpersonal, verbal, and written communication skills.
- Strong attention to detail.
- Experience with SAP or an equivalent ERP system.
- Experience working in an ISO 13485 or FDA-regulated environment is desirable.
Education and Experience
- Bachelor’s or master’s degree with two years of related experience.
- Preferred fields of study include Organic Chemistry, Chemistry, Molecular Biology, Biochemistry, Chemical Engineering, or Biochemical Engineering.
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