Sr. Quality Validation Engineer

Location

Camarillo, CA | United States

Job description

The Senior Quality Engineer is responsible for providing oversight of programs and procedures for qualification and validation of bioreactor systems (PBS products), facility, utilities, and equipment.  This role supports product development, product transfer, manufacturing, and commercialization of bioreactor products.  This role provides technical analysis of quality aspects of product quality, change assessments, and assessments of technical aspects of validations, qualifications, and certifications.  Role will also assist in providing technical information and material assessments to customers, as requested.

RESPONSIBILITIES

Essential functions of the job are listed below.  Other responsibilities may also be assigned.  Please note that the essential functions may vary depending on department size, organizational structure and/or geographic location.  Reasonable accommodations may be made to allow differently-abled individuals to perform the essential functions of the job.  

Primary Responsibilities

• Provides Quality leadership, defines product quality requirements to product development teams in the areas of testing, verification/validation, design transfer, product quality risks, material assessments, and specification development.
• Owns and implements material specification and qualification program. Owns and oversees related processes and procedures for material specification and qualification program.
• Quality contact and approver for requirements and documents which support product development, testing, verification, validation, and transfer of products including bioreactor control units (electromechanical), single-use bioreactor vessels, and controller software.
• Performs complex technical analysis and written assessments for product quality and compliance impact to validation due to changes or nonconformances. 
• Quality contact for qualification and validation for items related to manufacturing, facility, and equipment.
• Responsible for continuous improvements of assigned processes. Identify opportunities for and lead or participate in continuous improvement of the QMS program.
• Liaise between the Engineering and Quality departments to provide support of Engineering projects and to identify and coordinate improvements.
• Supports or manages procedure updates and improvements.
• Owns and authors product qualification validation reports and material assessments (product quality technical reports).
• QE is a Quality Assurance function and may provide QA approvals where trained and assigned.
• Support customer supplier audits as material specification and qualification subject matter expert/process owner.
• Assignments may vary based on business need .
• This role may have direct reports and supervise staff or contractors based on business need.

MINIMUM QUALIFICATIONS

The following are the minimum qualifications that an individual needs in order to successfully perform the duties and responsibilities of this position.  Please note that the minimum qualifications may vary based upon the department size and/or geographic location.

• The position requires experience with developing and validating medical devices, GMP bioprocessing equipment, or single-use medical products and requires the application of Quality Engineering methods and tools to define requirements for testing, verification, qualification, and validation.   This role requires effective leadership, collaboration, technical writing, and verbal communication skills.  This position reports to the Head of Quality.

Knowledge/ Experience

• 5+ years’ experience in a Quality role for medical products in a regulated environment (e.g. medical device, single-use medical and/or biopharma products, or similar field).
• 5+ years’ experience working in a quality system that requires a high degree of quality control, ideally GMP quality system, medical device (QSR/ISO13485), aerospace (AS9100), and/or ISO 9001.
• 3+ years in a technical or engineering role e.g., research, process development/engineering, manufacturing sciences, technical services, or analytical labs
• 4+ years in a validation or related role
• 3+ years using statistics, quantitative analysis, and similar analytical  tools.
• Knowledge of lean, six sigma ( e.g., DMAIC, DIDOV, etc.) and/or quality engineering (quality management system, product design and control, and continuous improvement, etc.) approaches and methodologies.

Skills/ Abilities Pertinent to This Position

• Methods and processes related to qualification, validation, characterization of product, process, facility, and  equipment.

• Program-level experience with validation or equivalent verification/validation, or qualification.
• Risk management techniques related to ICH Q9, ISO 14971, or similar standards, including designing and applying FMEA, risk priority assignment, to product or  process.
• Ability to author technical assessments for regulatory purposes related to Pharma/Biotech (FDA CFR 210/211, ISO 13485/FDA CFR 820, EMA/EU Pharma, USP, AS 9100, or other federally regulated industry
• Statistical analysis, statistical process control, statistical sampling/acceptance methods, design of experiments, and related techniques  
• Able to perform analysis to support material selection and qualification of pharmaceutical grade materials.
• Excellent technical writing and excellent verbal communication skills

PHYSICAL DEMANDS

In general, the following physical demands are representative of those that must be met by an employee to successfully perform the essential functions of this job.  Reasonable accommodations may be made to allow differently-abled individuals to perform the essential functions of the job.

Must be able to see, hear, speak and write clearly in order to communicate with employees and/or vendors; manual dexterity required for occasional reaching and lifting of small objects, and operating manufacturing and test equipment.  May occasionally required to lift various weights up to 50lbs as needed to meet job requirements. 

WORK ENVIRONMENT 

In general, the following conditions of the work environment are representative of those that an employee encounters while performing the essential functions of this job.  Reasonable accommodations may be made to allow differently-abled individuals to perform the essential functions of the job within the environment.

This role is primarily office work with some tasks or evaluation performed in a production or lab environment.  May be required to perform some tasks in the following environments: Clean room; Near moving mechanical parts, fumes, machine lubricants, airborne particles, vibration, and risk of electrical shock, high noise while in the manufacturing plant. Personal protective equipment (vision and hearing) used in plant.   

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