Senior Process Engineer – Downstream; Biologics & Peptides
Job in
Boulder, Boulder County, Colorado, 80301, USA
Listed on 2026-05-18
Listing for:
Stark Pharma
Full Time
position Listed on 2026-05-18
Job specializations:
-
Engineering
Process Engineer, Validation Engineer, Pharma Engineer, Biotechnology
Job Description & How to Apply Below
Job Title:
Senior Process Engineer Downstream (Biologics & Peptides)
Location:
Boulder, CO (100% Onsite)
Duration: 6 Months + Extensions
Start Date:
ASAP
We are seeking a Senior Process Engineer with strong expertise in downstream processing to support the development, scale-up, and commercialization of biologics and peptide-based therapeutics. This role will focus on designing, optimizing, and implementing purification processes and manufacturing systems within a GMP-regulated environment. The ideal candidate will have hands‑on experience with chromatography and tangential flow filtration (TFF) technologies, along with a proven track record supporting process scale‑up, equipment qualification, and manufacturing startup activities.
Key Responsibilities- Lead downstream process development and optimization activities for biologics and peptide products
- Design, specify, and support implementation of purification systems including chromatography and TFF skids
- Support process scale‑up from development through pilot and commercial manufacturing
- Drive startup, commissioning, qualification, and troubleshooting of downstream manufacturing equipment
- Develop and execute process validation and verification strategies aligned with GMP and regulatory requirements
- Collaborate with MSAT, Upstream, Manufacturing, and Quality teams to ensure process robustness and consistency
- Author and review technical documentation including process descriptions, validation protocols, and regulatory support documents
- Serve as a technical SME for downstream purification operations and technologies
- Mentor junior engineers and support continuous improvement initiatives
- Bachelor s, Master s, or PhD in Chemical Engineering, Biochemical Engineering, or related field
- 8+ years of experience in biopharmaceutical process engineering with strong downstream processing expertise
- Hands‑on experience with:
- Chromatography systems (affinity, ion exchange, HIC, etc.)
- Tangential Flow Filtration (TFF) systems
- Experience supporting equipment startup, commissioning, and qualification activities
- Strong understanding of process validation and GMP manufacturing environments
- Experience supporting or leading tech transfer and process scale‑up activities
- Strong troubleshooting, communication, and cross‑functional collaboration skills
Position Requirements
10+ Years
work experience
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