Senior Process Engineer - Global API Manufacturing (Remote)

Openkrill; United States; Remote; USD 110,000 - 125,000; Full time

Benefits offered by this job

Medical, dental and vision plans

401(k) matching up to 6%

Stock incentives and ESPP

Discretionary quarterly bonus

Generous PTO and company-wide shutdown

Job summary

Praxis Precision Medicines is seeking a Process Engineer to support CMOs, validate APIs, and contribute to knowledge transfer between Praxis and external partners. The role involves translating lab processes to scalable industrial methods and ensuring regulatory-ready data handling.

The ideal candidate has 4–8 years in chemical manufacturing or CMO settings, strong communication, and a commitment to cGMP standards, travel, and collaboration across teams.

Qualifications

• Bachelor’s or advanced degree in chemical engineering or related field.
• 4–8 years of applied experience in CMO management or chemical manufacturing.
• Experience reviewing batch records, SOPs, non-conformances, and change controls.

Responsibilities

• Translate lab synthesis to industrial scale by authoring scale-up spreadsheets and process manuals.
• Gather, analyze, and archive large data packages to support regulatory filings.
• Review CMOs’ documentation including batch records, procedures, and development reports.
• Work with Quality Assurance to ensure compliance with regulations and standards in third-party processes.
• Adhere to cGMP guidelines and industry standards.
• Identify process risks and help develop mitigation plans.
• Travel for in-person plant visits at CMOs (US and worldwide).

Skills

CMO management

Chemical manufacturing

Documentation review

Regulatory compliance

cGMPs

Cross-functional communication

Travel readiness

Education

Bachelor's in chemical engineering

MS or equivalent

Job description

Praxis Precision Medicines is seeking a Process Engineer to support CMOs, validate APIs, and contribute to knowledge transfer between Praxis and external partners. The role involves translating lab processes to scalable industrial methods and ensuring regulatory-ready data handling.

The ideal candidate has 4–8 years in chemical manufacturing or CMO settings, strong communication, and a commitment to cGMP standards, travel, and collaboration across teams.