Process Engineer II/Lead-OSD jobs in United States
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Astrix ยท 4 hours ago

Process Engineer II/Lead-OSD

Astrix is a company focused on manufacturing pharmaceutical products, and they are seeking a Process Engineer II/Lead-OSD. This role involves supporting the scale-up and transfer of oral solid dosage formulations to production, troubleshooting automated equipment, and implementing process improvements.

ConsultingInformation Technology
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Growth Opportunities
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H1B Sponsor Likelynote

Responsibilities

Troubleshoot and maintain manufacturing systems, processes, and equipment
Support the development or transfer of manufacturing and cleaning processes for the manufacturing area
"Hands-on" ability to install and troubleshoot instrumentation and equipment
Author high-quality technical protocols/reports (engineering studies, summary reports, equipment specifications, change controls, and investigations)
Specify and size manufacturing systems, equipment, and process equipment

Qualification

OSD pharmaceutical experienceCGMP knowledgeProcess scale-upStatistical analysisEquipment procurementTroubleshooting skillsCommunicationOrganizational skillsPositive attitude

Required

BS degree in Engineering or technical discipline
2-5 year of manufacturing experience or technical experience
Excellent communication and documentation skills
Excellent organizational skills
Ability to self-manage and prioritize workload
Ability to react quickly to understand and solve problems
Excellent troubleshooting skills
Fosters collaborative relationships within and across groups through influencing and negotiation skills
Positive attitude
Troubleshoot and maintain manufacturing systems, processes, and equipment
Support the development or transfer of manufacturing and cleaning processes for the manufacturing area
"Hands-on" ability to install and troubleshoot instrumentation and equipment
Author high-quality technical protocols/reports (engineering studies, summary reports, equipment specifications, change controls, and investigations)
Specify and size manufacturing systems, equipment, and process equipment

Preferred

2-5 years of OSD pharmaceutical experience or 5 years of pharmaceutical engineering experience
Experience with OSD equipment procurement
Thorough knowledge of cGMP, OSHA, EPA and FDA facility requirements and regulations
Thorough knowledge of OSD operations, statistics, equipment design, process control, and process scale-up
Knowledge of OSD pharmaceutical process and equipment validations
Experience in statistical analysis: sample sizing, ANOVA, regression analysis, control charts, etc

Benefits

Relocation assistance provided

Company

Astrix

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Astrix is the unrivaled market-leader in creating & delivering innovative strategies, solutions, and people to the life science community.

H1B Sponsorship

Astrix 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 (10)
2024 (9)
2023 (10)
2022 (16)
2021 (11)

Funding

Current Stage
Late Stage

Leadership Team

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Dale Curtis
Chief Executive Officer
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Reid E. Simpson
Chief Financial Officer
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Company data provided by crunchbase