Job Summary: TheValidation Engineer III isan intermediate level position.Under moderate supervision, theindividual will design, execute, and/or manage commissioning and validation projects for the lifecycle management of GxP Facilities, Utilities, Equipment, Instruments, Cleaning and Processes. This role will interact with cross-functional GxP groups such as Quality Control,Manufacturing, Facilities, IT, Supply Chain andRegulatory Affairs.
- Reporting to: Sr. Manager, Validation
- Location Newark, CA
- Salary Range: $102,465 - $140,921 + annual performance bonus
Responsibilities/Essential Duties:
- Design, execute, and/or coordinate commissioning, qualification, and validation activities as it relates to GxP Facilities, Utilities, Equipment, Cleaning, and Processes in accordance with company policies and US and international regulatory requirements.
- Support the Re-validation Program through scheduling, tracking, and execution of validation and periodic review activities to maintain the validated state of GxP Facilities, Utilities, Equipment, Instruments, Cleaning and Processes.
- Author, review and/or approve Validation Plans, Protocols, Specifications, Assessments and Reports.
- Authors and/or implements changes to controlled documents (e.g., Standard Operating Procedures, Work Instructions, Specifications, Methods, etc.) as needed.
- Own and process Quality Events (Deviations, Change Controls, and Corrective and Preventative Actions) for GxP Facilities, Utilities, Equipment, Instruments, Cleaning and Processes.
- Manage and coordinate the activities of assigned validation and contract personnel to ensure the quality of completed work.
- Provide technical expertise and interpretation on regulations and guidelines as they relate to validation activities.
- Support the development, collection, and management of program metrics and key performance indicators to optimize performance, productivity, and effective resource planning.
- Other duties as assigned.
Basic Qualifications:
- Master's degree & 2 years of directly related experience; OR
- Bachelor's degree & 4 years of directly related experience; OR
- Associate's degree & 6 years of directly related experience.
Preferred Qualifications:
- Bachelor's degreeor equivalent in biology, chemistry or related science,or equivalent experience.
- Minimum5years' GxP experience inpharmaceuticaland/orbiotechrelated fields.
- Working knowledge of quality systems cGMP standards applicable to biologic products.
- Knowledge of GAMP validation principles, manufacturing processes and quality systems.
- Knowledge of validation requirements (ISPE, FDA, etc.) for biopharmaceutical manufacturing facilities, equipment and systems.
- Works under moderate supervision.
- Ability to independently analyze and reconcile simple issues.
- Ability to organize and manage multiple tasks in a fast-paced environment, withminimalinstruction on routine work andmoderateinstructions on new assignments.
- Excellent verbal and written communication and interpersonal skills.
- Proficient with commonly used word processing, database systems, and other software.
Company Summary Revance is pleased to announce our recent merger with Crown! We're excited for this time of growth and opportunity, building on the strengths of both organizations. As a commercial-stage biotechnology company focused on innovative aesthetic and therapeutic offerings, we are setting the new standard for clients through disruptive products, and for employees through industry-leading benefits that promote financial and physical well-being for all. It's time to rethink everything you thought an employee experience could be. What Revance invests in you:
- Competitive Compensation including generous base salary and annual performance bonus.
- Flexible unlimited PTO, holidays, and 12 weeks parental leave.
- *Generous healthcare benefits, Employer HSA contribution, 401k match, wellness discounts and much more.
*Due to merger 2026 benefits are subject to change. This section of the job description is required by the American with Disability Act (ADA). The ADA requires that job descriptions reflect the physical and mental demands required to effectively perform the essential duties of the job. The ADA prohibits employers from discriminating against a "qualified individual with a disability" in all aspects of the employment relationship. A "qualified individual with a disability" is "an individual who meets the education, experience, skill, and other job-related requirements of a position held or desired, and who, with reasonable accommodation, can perform the essential functions of a specified job." We are an equal opportunity employer. We are a company where diverse backgrounds, experience and viewpoints are valued. Revance does not discriminate in practices or employment opportunities on the basis of an individual's race, color, national or ethnic origin, religion, age sex, gender, sexual orientation, marital status, veteran status, disability, or any other prohibited category set forth in federal or state regulations.
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