Staff Engineer, MSAT Validation
About The Position
The Staff Engineer, MSAT Validation supports sterile and aseptic manufacturing by leading validation activities across processes, cleaning, and media fill (aseptic process simulation) programs. This role helps maintain validated state, support compliant manufacturing operations, and drive effective, science- and risk-based validation strategies. This position may support one or more validation disciplines based on business needs, including process validation, cleaning validation, and media fill/aseptic process simulation. The role is expected to provide technical leadership on complex validation work while collaborating across functions in a sterile manufacturing environment.
Requirements
- Must be Legally authorized to work in the United States without sponsorship.
- Must be able to pass a comprehensive background check to include drug screening.
- Bachelor’s degree in Engineering, Chemistry, Life Sciences, or a related field.
- 8+ years of experience in pharmaceutical and/or biotechnology validation.
- Experience in sterile/aseptic manufacturing environments (required).
- Strong experience in one or more of the following: process validation/PPQ, cleaning validation, or media fill/aseptic process simulation.
- Experience with validation lifecycle activities and risk-based approaches.
- Strong understanding of aseptic processing, contamination control, and validated-state principles.
- Strong knowledge of cGMP and applicable regulatory requirements and expectations.
- Technical writing and documentation expertise, including validation protocols and reports.
- Data analysis, technical assessment, and problem-solving skills.
- Ability to lead complex validation projects independently and manage multiple priorities.
- Strong cross-functional collaboration, communication, and stakeholder management skills.
- Ability to support audits, inspections, investigations, deviations, change controls, and CAPAs.
Responsibilities
- Lead and/or support process validation (PPQ), cleaning validation, and media fill (aseptic process simulation) activities for sterile/aseptic manufacturing processes.
- Develop validation strategies for new and existing products, processes, and cleaning procedures using lifecycle and risk-based approaches.
- Author, review, and execute validation protocols, reports, risk assessments, and related technical documentation.
- Perform data analysis and technical assessment to support validation conclusions and ongoing maintenance of the validated state.
- Support investigations, deviations, change controls, and CAPAs associated with validation and aseptic manufacturing activities.
- Partner cross-functionally with Manufacturing, Quality, MS&T/Manufacturing Science, and Regulatory teams to deliver validation programs.
- Ensure validation activities align with cGMP and applicable global regulatory expectations, including FDA and EMA requirements.
- Support internal and external audits and inspections and contribute to continuous improvement of validation and contamination control strategies.
Benefits
- Medical, Dental, & Vision benefits-effective Day 1
- Paid Time Off & Holidays
- 401K Company Match up to 6%(after 1 year)
- Tuition Reimbursement – eligible after 90 days
- Employee Referral Bonus
- Employee Discount Program
- Recognition Program
- Charitable Gift Matching
- Company Paid Parental Leave
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What This Job Offers
Job Type
Full-time
Career Level
Senior
