4423 Senior Quality Engineer
The Opportunity:
In this exciting role, you will apply knowledge of qualification and validation principles, manufacturing processes, quality systems, engineering design fundamentals, health authority expectations and industry standards to provide quality oversight for the site qualification/validation program.
You will perform quality oversight of qualification and validation activities associated with equipment, facility and utility systems, GMP computerized systems, drug product manufacturing processes, cleaning processes, sterilization processes, and analytical methods.
This is inclusive of, and primarily in support of, technology transfer and process validation.
You will provide guidance to internal customers on best practices for executing consistent, reproducible, and compliant qualification and validation activities.
You will provide assessment and approval for changes that impact the validated state and/or require qualification/validation.
You will review and approve a variety of documents to support qualification and validation activities, ensuring compliance with internal quality system requirements.
You will provide input and quality oversight to qualification/validation exceptions/deviations.
You will work on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors, including inter-organizational impact.
You will exercise judgment based on the analysis of multiple sources of information and interactions with peers and cross-functional squads.
Who you are:
You hold a Bachelor’s degree with 8 years industry experience or Master’s degree with 5 plus years.
You have biopharmaceutical or pharmaceutical industry experience in technical validation or quality validation, and strong technical knowledge of qualification and validation principles.
You have an ability to interpret and relate quality standards for implementation and review.
You have the ability to make sound decisions about quality and technical subjects.
You exhibit sound knowledge of cGMPs or equivalent regulations.
You have flexibility in problem solving and work hours to meet business objectives.
You are able to quickly and consistently establish rapport and collaborate effectively with team members and partners.
The hiring range for this position is $85 to $112 per hour. The base pay actually offered will take into account internal equity, and may also vary depending on candidate’s geographic region, job-related knowledge, skills, and experience amongst other factors
Harvest Technical Services is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, Sexual orientation, national origin, genetics, pregnancy, disability, age, veteran status, or any other federal, state, or local protected class.