Validation Engineer I/II

This position provides technical knowledge and execution for process and cleaning validation to support commercial cGMP manufacturing for both sterile injectables and oral solid dose products and ensure compliance with internal and external policies and regulations.

Essential Areas of Responsibility

Validation

• Provide execution support for cleaning validation and process validation testing.
• Author cleaning and process validation protocols and reports.
• Support cleaning verification, validation and requalification testing. 
• Perform peer review on executed protocols.
• Author and update Standard Operating Procedures (SOP’s).
• Adhere to site and global procedures and practices. 
• Adhere to applicable regulatory and industry guidelines and requirements. 

Qualifications

Minimum education and experience requirements

• BS in engineering or scientific field. 
• At least 4+ years validation pharmaceutical industry experience, or 6+ years general commercial pharmaceutical industry experience. 

Preferred Technical Knowledge/ Skills

• Able to interact and coordinate with cross functional teams to execute actions for validation studies and in support of projects.
• Able to gown into classified areas for sampling and validation execution.
• Experience in sterile and oral solid dosage pharmaceutical processes a plus.     
• Able to problem solve and apply critical thinking skills.
• Excellent written and verbal communications, including technical writing.  MS Office proficiency. 
• Experience with Trackwise, Veeva, SAP, and Valgenesis is preferred.
• Positive attitude

Work Environment

• Work will be split between contained manufacturing area and office
• This position is eligible for a hybrid work schedule, which combines onsite and remote work models to create a unique and more flexible work environment. At the discretion of the manager, established employees are eligible for up to two days remote work per week. Hybrid work expectations will be evaluated on an ongoing and periodic basis. 
• Must be able to pass a pulmonary function tests if required by doctor 
• Must be able to wear respiratory protective equipment

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