You are applying for a position through Medix, a staffing agency. The actual posting represents a position at one of our clients.
Job Summary
Our client is seeking a Validation Engineer to execute process validation activities across the full validation lifecycle for biologics manufacturing. The primary responsibilities include supporting both upstream and downstream manufacturing processes, authoring and reviewing validation documentation, performing data analysis, and ensuring alignment with regulatory expectations and industry best practices.
Key Responsibilities
- Execute process validation activities across the full validation lifecycle for biologics manufacturing.
- Support upstream and downstream manufacturing processes, including chromatography operations and parameter evaluation.
- Author and review validation documentation, including Validation Master Plans (VMPs), protocols, reports, risk assessments, and PFMEAs.
- Perform data analysis and support validation studies for clinical phase manufacturing (Phase 1–3).
- Collaborate cross-functionally with manufacturing, quality, and technical operations teams.
- Support regulatory inspections and internal audits during busy periods.
- Ensure validation activities are aligned with current regulatory expectations and industry best practices.
Qualifications
- 5–10 years of relevant work experience; 5–10 years experience with Validation Master Plans; understanding of biological processes.
- Experience supporting drug substance and/or drug product manufacturing.
- Prior consulting or contract experience in regulated biologics environments (preferred).
Experience
- Minimum 5–10 years of experience in relevant field.
- Specific experience with Validation Master Plans and understanding of biological processes required.
Additional Requirements
- Work schedule is 8AM to 5PM, Monday through Friday.
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 that an average of 30 hours per week during the first 4 weeks of the work assignment has been met. If you meet eligibility requirements and take action to enroll, you will be covered no earlier than 60 days into your 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).
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.
*As a job position within our Life Sciences division, a successful completion of a background check may be required as a condition of employment. This requirement is directly related to essential job functions including but not limited to: high-risk work environments (warehouse or industrial areas), high-risk/ high-error job duties that could result in life-threatening injury or death, operation of heavy-duty machinery, working with hazardous chemicals, exposure to other dangerous materials, such as drugs and sharp instruments. Due to these job duties, this position has a significant impact on the 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.
