[Hiring] Process Engineer @Praxis Precision Medicines, Inc.

Role Description

Praxis is seeking a highly skilled Process Engineer to partner closely with our Contract Manufacturing Organizations (CMOs), driving the validation and optimization of processes for primary and secondary drug product packaging. The ideal candidate brings hands-on engineering experience, thrives in a collaborative, fast-moving environment, and serves as the primary point of contact between Praxis and our CMOs, ensuring clear, efficient communication and seamless knowledge transfer.

• Deep knowledge of primary and secondary packaging materials and processes for oral drug products as well as labeling and serialization requirements.
• Bottling, blistering, walleting, cartoning of oral drug products, including tablets, gel caps, and powders.
• Cold chain and parenteral knowledge, a plus.
• Efficient use of technologies and applications to gather, analyze and archive large data packages that can support regulatory filings.
• Review relevant documentation from CMOs and lab partners including instructions, procedures, batch records, non-conformances, in-process controls, bulletin of analysis, developmental reports.
• Work alongside Quality Assurance to ensure all proper regulations and standards are followed in all our processes being executed by third parties.
• Adhere to industry guidelines, standards and laws including being well-versed in cGMPs.
• Travel required - PIP at CMOs (US and worldwide).

Qualifications

• Degree in packaging, mechanical or other relevant engineering field, MS or equivalent a plus.
• Pharmaceutical experience required.
• 5 years’ with a BS degree or 2 years’ with an MS degree of applied experience in CMO management, final drug product manufacturing, or comparable positions that handle diverse environments, reviewing Manufacturing and Executed Batch records, operating procedures, non-conformances, change controls, and fostering business partner relationships.
• Excellent written and visual communication skills with an ability to build relationships internally and externally.
• Self-motivated and able to contribute to a productive and collaborative team environment.
• Highly organized and detail-oriented with a passion to deliver quality results.

Benefits

• 99% of the premium paid for medical, dental, and vision plans.
• Company-paid life insurance, AD&D, disability benefits, and voluntary plans to personalize your coverage.
• 401(k) contributions matched dollar-for-dollar up to 6%.
• Long-term stock incentives and ESPP.
• Discretionary quarterly bonus.
• Flexible wellness benefit.
• Generous PTO, paid holidays, and company-wide shutdowns.

Company Description

Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders characterized by neuronal imbalance. At Praxis we share a common vision of reshaping the human condition into a more freeing and fulfilled existence by developing high impact medicines for patients and families affected by and living with complex brain disorders. Our core Values of Trust, Ownership, Curiosity and Results are foundational to every aspect of our business and are exemplified by each and every one of our team members.

• Diversity, Equity & Inclusion: Guided by our core values, at Praxis Precision Medicines, Inc. we continue to DARE FOR MORE® to advance, promote, and champion diversity, equity, and inclusion by encouraging individuals to bring their authentic selves and perspectives to work each day.
• We are an equal opportunity employer and committed to providing opportunities to all qualified applicants without regard to race, religious creed, color, gender identity or expression, age, national origin, sexual orientation, disability, genetics, military service and veteran status, or any other characteristic protected by federal, state, or local laws.