Manager/Senior Manager, Process and Cleaning Validation

Scorpion Therapeutics; Durham (NC); On-site; USD 120,000 - 180,000; Full time

Job summary

Scorpion Therapeutics seeks a senior process and cleaning validation lead to manage programs for biopharmaceutical manufacturing during early-stage development. You will develop validation master plans, protocols, and reports; conduct risk assessments and gap analyses; evaluate equipment and procedures; support regulatory submissions and inspection readiness; train personnel; and oversee a 3–5 person validation team including contractors.

Travel up to 25% is expected.

Qualifications

• Bachelor's degree in Engineering, Chemistry, or related field required.
• 8+ years in biopharma manufacturing validation.
• Strong project management and technical documentation skills.
• Leadership experience with 3–5 person team preferred.

Responsibilities

• Develop validation master plans, protocols, and reports.
• Conduct risk assessments and gap analyses.
• Evaluate equipment and process procedures as part of validation.
• Support regulatory submissions and inspection readiness; train personnel and oversee contractors.

Skills

Project management

Technical documentation

Team leadership

Validation knowledge

Risk assessment

Gap analysis

Training

Education

Bachelor's degree in Engineering, Chemistry, or related field

Tools

Smartsheets

Job description

Role:

Manage and lead process and cleaning validation programs for biopharmaceutical manufacturing, supporting early-stage process validation strategies.

Responsibilities

develop validation master plans, protocols, and reports; conduct risk assessments and gap analyses; evaluate equipment and process procedures; support regulatory submissions and inspection readiness; train personnel; author and review validation documentation; oversee 3-5 validation team members including contractors; escape technical or schedule issues.

Requirements

Bachelor's in Engineering, Chemistry, or related; 8+ years supporting biopharma manufacturing validation, with experience in process validation, cleaning validation, or process engineering; strong project management and technical documentation skills; team leadership experience.

Preferred

experience with LNP processes/equipment; knowledge of FDA, EMA, ICH validation guidelines; understanding of process design, CIP/COP systems, and analytical validation; familiarity with statistical validation methods; proficiency with Smartsheets.

Travel

Travel: up to 25%.

Work setup

Work setup not specified.