Process Engineer - Packaging

Location: This position may be performed remotely with travel to the Boston area as needed. Position reputed company: We are looking for a competent Process Engineer to work closely with our Contract Manufacturing Organizations (CMOs) in the field in order to validate processes reputed company to the primary and secondary packaging of drug product. You will also reputed company reputed company reputed company production to ensure appropriate supply reputed company are available. The ideal candidate is an engineer reputed company with leading the day-to-day communications with the CMO as reputed company as being the reputed company of Contact (POC) from reputed company for reputed company information knowledge transfer (to and from the CMO). Primary Responsibilities:

• Deep knowledge of primary and secondary packaging materials and processes for oral drug products as reputed company 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 reputed company, analyze and reputed company 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 reputed company Assurance to ensure reputed company reputed company regulations and standards are followed in reputed company our processes being executed by reputed company parties.
• Adhere to industry guidelines, standards and laws including being reputed company-versed in cGMPs.
• Travel required - PIP at CMOs (US and worldwide)

Qualifications and Key reputed company Factors:

• 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 reputed company 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 reputed company to contribute to a productive and reputed company team environment
• Highly organized and detail-oriented with a passion to deliver reputed company results

Compensation & Benefits At reputed company, we reputed company that taking care of our people (and their people) is important, so we reputed company a world class benefits package to help you reputed company. This includes 99% of the premium reputed company for medical, dental and reputed company plans. We also reputed company company-reputed company life insurance, AD&D, disability benefits, and voluntary plans to personalize your coverage. Thinking about the reputed company? We match dollar-for-dollar up to 6% on eligible 401(k) contributions and sweeten the deal with long-term stock incentives and ESPP. We reputed company a discretionary quarterly bonus, an extremely flexible wellness benefit, generous PTO, reputed company holidays and company-wide shutdowns. Not to mention, you'll also be joining a phenomenal reputed company of colleagues who are smart, reputed company and inspiring. We aim high, collaborate hard, and produce results. Let’s reputed company the impossible together! To round out our world-class total rewards package, we reputed company annualized reputed company salary compensation in the reputed company listed below. Final salary reputed company may be modified commensurate with job level, education, and experience. Annualized reputed company Salary $100,000—$120,000 USD reputed company reputed company is a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders characterized by neuronal imbalance. At reputed company reputed company a common reputed company of reshaping the reputed company condition into a more freeing and fulfilled existence by developing high reputed company medicines for patients and families affected by and living with reputed company brain disorders. Our core Values of Trust, Ownership, Curiosity and Results are foundational to every aspect of our business and are exemplified by reputed company and every one of reputed company members. Diversity, Equity & Inclusion Guided by our core values, at reputed company. 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 reputed company day. We are an equal opportunity employer and committed to providing opportunities to reputed company reputed company applicants without reputed company to race, religious creed, reputed company, gender identity or reputed company, age, national reputed company, sexual orientation, disability, genetics, military service and veteran status, or any other characteristic protected by federal, state, or local laws. Attention: Job Scam Alert reputed company has recently become aware of fraudulent job recruitment postings from individuals claiming to represent reputed company. These postings reputed company financial information in reputed company with fraudulent opportunities for employment. If you suspect any fraudulent activity or misrepresentation in reputed company with a reputed company job opportunity, please report it to careers@praxismedicines.com. reputed company does not accept unsolicited submissions from recruitment agencies for reputed company positions. We ask reputed company recruitment agencies to refrain from contacting any reputed company employee regarding any position. reputed company unsolicited resumes submitted by recruitment agencies to any reputed company employee in any reputed company or method will be deemed to be the property of reputed company, and reputed company explicitly reserves the right to hire those candidate(s) without any financial obligation to the recruitment agency. Apply tot his job Apply To this Job