Unicon Pharma Inc · 2 weeks ago
Process Engineer (Capital Expansion)
Pennsylvania, United States
Contract
Hybrid
Senior Level
$60/hr - $75/hr
5+ years expUnicon Pharma Inc is seeking an experienced Process Engineer to support a capital expansion project at a leading biotech manufacturing facility in NC. The Process Engineer will play a key role in process design, equipment integration, commissioning, qualification, and start-up activities for new and expanded manufacturing operations.
BiotechnologyMedicalPharmaceutical
Hiring Manager
Amber Gibbons, MS
Responsibilities
Support process design, scale-up, and implementation activities for capital expansion and new manufacturing areas
Collaborate with Engineering, CQV, Operations, Quality, and Facilities teams throughout project execution
Develop and review process flow diagrams (PFDs), piping and instrumentation diagrams (P&IDs), mass and energy balances, and process specifications
Provide process input for equipment selection, URS development, vendor coordination, and FAT/SAT activities
Support Commissioning, Qualification, and Validation (CQV) activities including protocol development, execution, and deviation resolution
Ensure processes comply with cGMP, FDA, and regulatory requirements
Assist in process risk assessments (FMEA, HAZOP) and implement mitigation strategies
Support start-up, troubleshooting, and process optimization during initial operations
Author and review technical documentation, SOPs, batch records, and change controls
Participate in capital project meetings, timelines, and deliverables to ensure on-time execution
Qualification
Required
Bachelor's degree in Chemical Engineering, Biochemical Engineering, Biotechnology, or related field
5+ years of process engineering experience in biotech, pharmaceutical, or life sciences manufacturing
Hands-on experience supporting capital expansion, new facility, or major equipment installation projects
Strong understanding of biotech manufacturing processes (upstream, downstream, or fill-finish)
Working knowledge of cGMP, FDA regulations, and CQV practices
Experience supporting equipment commissioning and qualification activities
Ability to work effectively in a fast-paced, project-driven environment
Preferred
Experience supporting large-scale biotech manufacturing facilities
Familiarity with single-use systems, bioreactors, filtration, chromatography, or aseptic processing
Strong communication and stakeholder management skills
Company
Unicon Pharma Inc
Unicon Pharma provides customized workforce solutions for life sciences companies, bringing innovative treatments from concept to reality.
201-500 employees
H1B Sponsorship
Unicon Pharma Inc has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (71)
2024 (58)
2023 (71)
2022 (80)
2021 (91)
2020 (87)
Funding
Current Stage
Growth StageLeadership Team
Ravi Kollipara
CEO
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