You are applying for a position through Medix, a staffing agency. The actual posting represents a position at one of our clients.
Job Summary
The Manufacturing, Science and Technology (MSAT) Engineer will play an essential role in driving collaboration between the research and development, manufacturing, training, and other teams. The primary goal is to introduce new projects and transfer existing projects from R&D to GMP facilities focused on theragnostic radiopharmaceutical manufacturing. Key responsibilities include performing tech transfer tasks, supporting operational readiness, and training new and existing staff on equipment and processes.
Key Responsibilities
- Support radiopharmaceutical manufacturing throughout the product lifecycle.
- Work cross-functionally to onboard new equipment and processes.
- Ensure strict adherence to quality, safety, regulatory guidelines and written procedures.
- Document specifications, risk assessments, SOPs, batch records, and logbooks.
- Develop product understanding and control strategies.
- Collaborate with supply chain for necessary equipment orders and support engineering/maintenance efforts.
- Perform investigations, deviations, root cause analysis, and non-compliance reports with quality assurance.
- Optimize manufacturing efficiencies and manage material workflows.
- Perform additional job-related duties as assigned.
Qualifications
- Bachelor’s degree in a STEM field such as chemistry, engineering, or biology.
- Minimum 5 years of relevant experience in an FDA CGMP regulated environment with 21 CFR Parts 210 and 211.
- Experience in radiopharmaceutical manufacturing, aseptic processing, and designing documentation on hot cell functionality.
- Familiarity with automated synthesis units, dispensing units, and packaging automation.
Skills
- Mechanical aptitude and scientific background.
- Competency in troubleshooting manufacturing equipment and process issues.
- Strong teamwork, multi-tasking, and time management skills.
- Excellent communication, interpersonal, collaboration skills, and proficiency in Microsoft Suite.
- Ability to work independently and drive deliverables to completion within deadlines.
Additional Requirements
- Ability to travel up to 50%.
- Capable of frequent crawling, stooping, crouching, kneeling; lifting up to 50 lbs.
- May need to undergo respiratory fit tests.
- Ability to work in a cleanroom and sterile compounding environment.
- Must report health conditions that could impact product integrity.
Benefits
- Paid Sick Leave (Medix provides paid sick leave according to state and local sick leave ordinances).
- Health Benefits / Dental / Vision (Medix offers 6 different health plans: 3 Major Medical Plans, 2 Fixed Indemnity Plans (Standard and Preferred), and 1 Minimum Essential Coverage (MEC) Plan. Eligibility for health benefits is based on verifying an average of 30 hours per week during the first 4 weeks of the work assignment. Coverage begins no earlier than 60 days into the assignment, depending on plan selection(s)).
- 401k (Eligible on the first 401k open enrollment date following 6 consecutive months on assignment. 401k Open Enrollment dates are 1/1, 4/1, 7/1, and 10/1).
- Short Term Disability Insurance.
- Term Life Insurance Plan.
*We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable federal, state, and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance (FCIHO), Los Angeles Fair Chance Ordinance for Employers (ULAC), The San Francisco Fair Chance Ordinance (FCO), and the California Fair Chance Act (CFCA).
This position is subject to a background check based on its job duties, which may include patient care, working with vulnerable populations, access to financial and confidential information, driving, working with heavy machinery, or working in a warehouse or laboratory environment. Due to these job duties, this position has a significant impact on business operations and reputation, as well as the safety and well-being of individuals who may be cared for as part of the job position or who may interact with staff or clients.
Medix Overview:
With over 20 years of experience connecting organizations with highly qualified professionals, Medix is a leading provider of workforce solutions for clients and candidates across the healthcare, scientific, technology, and government industries. Through our core purpose of positively impacting lives, we’re dedicated to creating opportunities for job seekers at some of the nation's top companies. As an award-winning career partner, Medix is committed to helping talent find fulfilling and meaningful work because our mission is to help you achieve yours.
