QA VALIDATION ENGINEER (QA-004)

General Job Description/Team Overview:

This position will mainly be focused on establishing a validation strategy and validation master plan to ensure that critical quality supporting systems (i.e., equipment, instruments, utilities, computer systems, etc.) function consistently and efficiently to produce high-quality products. The candidate will establish a risk management strategy and work closely with system owners and technical authorities to conduct risk assessments to execute the validation program. The level will be determined based upon the candidate’s education, skills, and/or related experience.

Primary Duties and Responsibilities (include but are not limited to):

· Establish a phase appropriate validation program using a risk management strategy, risk-based assessment criteria, and methodology to execute the program.

· Establish and manage the GenVivo validation master plan, matrix, and schedule.

· Review and approve changes to critical systems through the change control program to ensure that changes to systems or equipment within the established manufacturing system do not negatively affect the outcome.

· Support development and execution of validation. 

· Provide quality oversight for and support execution of qualification and validation activities, including, but not limited to development, review, approval, and execution of protocols, procedures, and other supporting documentation.

· Coordinate and document validation efforts with system owners.

· Perform statistical analysis of data generated by validation studies and compile relevant documentation.

· Qualify, on-board, and oversee validation consulting services and ensure consultants comply with cGMPs and company procedures/policies. 

· Investigate the causes or provide quality oversight in the investigation of equipment failures and anomalies, and assist in the disposition of the equipment. 

· Collaborate with system/process owners to establish equipment and user requirement specification documents for new and existing equipment.

· Author and/or revise standard operating procedures for equipment operation and maintenance.

· Promote a collaborative team environment that fosters creativity, innovation, and quality compliance.

· Develop and provide training to appropriate personnel related to facilities and equipment quality systems to build quality awareness.

· Perform other duties as assigned.

Required Qualifications:

· Bachelor’s degree (or higher), preferably in Engineering, Life Sciences or Computer Sciences.

· At least 3 years of relevant experience in validation and/or engineering in biotech and/or biopharmaceutical setting with GMP manufacturing operations.

· Expert skillset of risk analysis, problem-solving, and technical writing.

· Proficient in handling multiple responsibilities, tasks, and projects simultaneously with the ability to change priorities.

· Working knowledge and experience with equipment qualification (IQ/OQ/PQ) and computer systems. 

· Ability to find creative solutions to complex engineering problems and to make solid decisions and take appropriate actions in a rapid-paced, forward evolving environment.

· Must have strong documentation bias, a methodical mind, analytical thinking, and attention to detail.

· Proficient in computer skills including Microsoft Office (Word, Excel, PowerPoint) and others as applicable.

· Excellent organization skills with attention to detail and accurate record keeping.

· General knowledge of Federal and State regulatory requirements in a GxP environment.

· High degree of discretion dealing with confidential information.

· Ability and willingness to work flexible hours when needed.

· Demonstrated ability to work independently and in a team environment.

· Excellent written, verbal, and interpersonal communication skills.

Eligible to work in the U.S. 

Compensation Range: $100,000-$180,000

Job Type: Full-time