KBI Biopharma

The Validation Engineer ll/III will be responsible for facilitating the validation lifecycle process for the Validation Department to ensure all equipment and systems are in a qualified state suitable for the intended use. This may entail, assisting with the planning, development, project management, and execution of life cycle engineering and validation lifecycle documentation elements of engineering and validation lifecycle design, commissioning, maintenance, qualification, and the interfaces with quality system lifecycle compliance requirements.

Responsible for data retrieval, compilation, verification, and comparative analysis from a variety of paper and electronic system formats. This will include authoring of studies, protocols, test scripts, and data tables to facilitate collection, expert data analysis/verification, summary reporting, and conclusions regarding acceptance criteria for validation studies conducted for new facility and equipment projects and requalification. The role will also be generally responsible for maintaining and accessing the validation documentation archive to fulfill internal/external client and/or auditor requests. In addition, there will be tasks related to coordinating validation support for Quality Event processes related to Change Controls, Deviations, CAPAs, and Audit Observations.

This position will provide support for more than one area of subject matter expertise for validation disciplines which may include: Facilities qualification, Utilities qualification, Equipment qualification, Manufacturing process control system qualification and Cleaning validation.

Job Responsibilities:

• Act as responsible Subject Matter Expert in drafting, execution, and review/approval of validation studies/reports
• Conform to all cGMP requirements for documentation and data integrity
• Validation support of Quality processes (Change Control; Deviation etc.)
• Support risk and impact assessments pertaining to validation work processes
• Support generation and/or review/revision to Engineering/Validation Specifications (URS, FRS, DDS etc.)
• Review and update department SOPs as required.

Minimum Requirements

Knowledge, Skills, Abilities

• Bachelor’s degree in Chemical Engineering, Industrial Engineering, Biomolecular Engineering, Mechanical Engineering, or related scientific field.
• Validation Engineer II: Three (3) to five (5) years of experience as a Validation Engineer, Equipment Specialist, Engineer, or related role in the pharmaceutical/biotechnology industries.
• Validation Engineer III: Five (5) to Seven (7) years of experience as a Validation Engineer, Equipment Specialist, Engineer, or related role in the pharmaceutical/biotechnology industries.
• Demonstrated ability to work in a team environment and strong communication skills within all levels of an organization.
• Technical Writing; Literacy in Engineering Documentation review/interpretation; Performing Equipment/System Risk Assessment for validation testing; Protocol management in development; field execution; deviation resolution and authoring and closure of final reports. 

Language Ability

• Ability to read and interpret English documents such as safety rules, operating and maintenance instructions, procedure manuals, batch and production records. 
• Ability to write routine reports and correspondence. 
• Ability to speak effectively before internal groups or employees of organization.
• Efficient and effective deductive and inductive critical thinking and problem-solving skills required.

Reasoning Ability

• Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization or data may exist.
• Ability to interpret and apply a variety of instructions furnished in written, oral, diagram, or schedule form.
• Strong time management skills and an ability to multitask in a face paced environment. Ability to deliver consistent high-quality documentation paying attention to detail and thoroughness relative to SOP requirements.
• Ability to quickly grasp complex technical concepts and make them understandable and corollary in text and graphics.

Math Ability

• MS Excel and spreadsheet creation and analysis
• Ability to add, subtract, multiply, divide, and convert in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent and to draw and interpret bar graphs.

Salary Range:

Validation Engineer II: $70,156 - $96,465

Validation Engineer III: $88,500.00 – $121,000.00

Salary range provided per current averages and expectations. The salary and job title for this opening will be based on the selected candidate’s qualifications and experience and may be outside this range.

KBI Biopharma is committed to providing a safe and healthy workplace. Any employee entering a KBI site located in the US must inform KBI Biopharma of their vaccination status and must submit their vaccination status. All vaccinated employees are required to provide proof of their COVID-19 vaccination, with a COVID-19 vaccination which has been granted FDA approval or Emergency Use Authorization.

KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply.

I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary.

I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.