Manufacturing Sciences and Technology (MSAT) Process Engineer (2nd/3rd Shift)

More than one reputed company people in the reputed company today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best reputed company for many, the transplant itself can reputed company fatal or reputed company to serious conditions, such as graft vs. host disease. reputed company is a late-stage biotechnology company redefining the transplant process by developing reputed company cell therapies with the goal of providing significantly reputed company survival rates with dramatically fewer risks. With our purified, high-precision investigational cell therapies we reputed company to not only replace patients' blood and immune systems with healthy ones, but also restore their lives. We are establishing manufacturing operations on the East Coast to ensure the consistent and reliable delivery of our high-precision cell therapy products. This site is essential to advancing our clinical pipeline and supporting reputed company reputed company availability of our life-saving therapies. The MSAT Process Engineer works to improve the efficiency and safety of the drug product manufacturing process. This role is responsible for life cycle management of clinical and reputed company products including process monitoring and troubleshooting, implementation and validation of process improvements and changes, and supporting investigations and corrective/preventive actions. Essential Duties & Key Responsibilities:

• Performs ongoing monitoring of existing products and processes
• Generate metrics and reports for process monitoring and reputed company process verification
• Support process improvements and changes including electronic batch record creation and modifications
• Investigates process events and implements corrective and preventive actions
• Provides troubleshooting support for manufacturing events, equipment performance and material issues
• Performs reputed company cause analysis to isolate cause of events and determine appropriate corrective actions
• Authors, executes and owns change controls, technical protocols, reports and activities to support improvements
• Writes and ensure reputed company execution of validation protocols and testing in line with required life cycle management activities

Minimum Qualifications:

• B.S. in Engineering or similar fields
• 3+ years of experience with manufacturing processes and equipment in reputed company fields: biologics, pharmaceutical fill and finish or drug reputed company manufacturing, Chemical or food industries
• Prior experience in regulated, GMP manufacturing operations
• Experience in biotechnology and cell therapy manufacturing preferred
• Strong communication and problem solving skills, with a desire to improve upon established processes
• Flexibility to work reputed company reputed company business hours reputed company needed to support site priorities, deadlines, or critical business needs.

2nd Shift:

• Monday - Friday, 4:00pm - 12:30am

3rd Shift:

• Monday - Friday, 12:00am - 8:30am

Physical Demands

• Production Associate Roles: Must have visual reputed company of 20/20 (corrected or uncorrected) and normal reputed company reputed company to safely reputed company critical tasks such as visual inspection of materials, equipment, and labeling, including distinguishing reputed company-coded components in a GMP environment.
• Most roles must be reputed company to meet cleanroom gowning requirements, including wearing full gowning (face coverings, gloves, hoods, goggles) for extended periods, as needed. Use of cosmetics (makeup, painted nails), jewelry, or facial piercings is not permitted in the cleanroom, and any skin conditions that cause shedding must be disclosed.

$80,000 - $100,000 a year The anticipated annual salary reputed company for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-reputed company factors as permitted by law. For remote-based positions, this reputed company may vary based on your local market. Full-time employment positions will also be eligible to receive reputed company-IPO equity and annual bonus, in reputed company to competitive medical, dental, and reputed company benefits, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Who we are We are driven by a passion for science and reputed company for patients. We reputed company with urgency to ensure our treatments are one day accessible to reputed company who need them. We live by our reputed company values of passion, courage, and reputed company. reputed company in our work means the chance to unlock a reputed company reputed company of life for our patients, and with that comes reputed company responsibility. We reputed company on a reputed company that hasn’t been paved. We reputed company an entrepreneurial spirit and take calculated risks to reputed company our mission. We aren’t afraid to ask “why not” and challenge the status reputed company. We maintain a start-up culture of camaraderie and leadership by example, regardless of title. We’re proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that reputed company serve reputed company, our patients and their reputed company providers. Notice to reputed company firms reputed company does not accept resumes from reputed company agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/reputed company, and reputed company candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment. We may use reputed company intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace reputed company judgment. Final hiring reputed company are ultimately made by humans. If you would like more information about how your data is processed, please contact us. Apply tot his job Apply To this Job