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Advanced Quality Validation Engineer

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Bio-Techne

2mo ago

  • Job
    Full-time
    Entry Level
  • Saint Paul

AI generated summary

  • You need strong experience in quality validation, an understanding of regulatory standards, and expertise in advanced engineering processes to ensure product integrity and compliance.
  • You will perform advanced quality validations, ensure compliance with standards, analyze data, troubleshoot issues, and collaborate with cross-functional teams to enhance product quality.

Requirements

  • Bachelors Degree in Engineering, Life Sciences or related discipline, with a minimum of 5-10 years of relevant experience performing validation activities within a pharmaceutical/ bio-technology environment; or equivalent combination of education and experience.
  • Must possess knowledge of and adhere to Company and departmental policies and procedures, as well as government regulations.
  • Must possess knowledge of current Good Manufacturing Practice (cGMPs), Annex 1, GAMP 5, 21CFR Part 210, Part 211, and Part 11. Knowledge of EudraLex - Volume 4 and World Health Organization (GMP) guidelines preferred.
  • Understand the regulatory requirements (ISO9001, ISO13485, CFR210/211, ISO 14001)
  • A background in pharmaceutical science or engineering, and equipment/computerized system validation is advantageous. Knowledge and understanding of pharmaceutical manufacturing equipment, facilities, and laboratory instrumentation preferred. Familiarity with Manufacturing, Regulatory Affairs, Quality Assurance, and Quality Control environments is advantageous.
  • Must possess excellent organizational and deductive reasoning skills.
  • Strong communication and written skills are required.
  • Knowledge of process equipment, such as bioreactors, chromatography systems, CIP, and autoclave
  • Knowledge of biological process, such as fermentation, protein purification
  • Experience with fill and finish of lyophilized materials
  • Experience with cGMP manufacturing and clean utilities, such as clean steam, cleanair, and WFI systems
  • Knowledge of cGMP manufacturing regulations for the FDA, EU and other countries as required
  • Assist in commissioning new buildings
  • Software validation experience
  • Understanding of equipment User Requirements/Risk Assessments
  • Attention to detail required to determine adequacy of testing results
  • Excellent computer skills

Responsibilities

  • Responsible for the validation studies required for qualifying Manufacturing, Packaging equipment and Facility and Utilities, including: Classified areas, HVAC Systems for Clean Classified Areas, USP Water-for-Injection, Clean Compressed Air, and nitrogen.
  • Support Media Fills - Protocols and reports generation.
  • Support development and enhancement of Equipment Facility and Utility qualification programs in accordance with current data integrity and cGMP best practice expectations. Oversee management of qualification protocol development. Oversee applicable computerized system administration. Ensure compliance with FDA, USP, EU, federal and state agencies, and applicable global health authorities.
  • Participate in development of risk based, quality driven procedures and practices with respect to engineering, qualification and validation. Develop and enhance validation programs to reflect current, best practice regulatory expectations and support the business model and objectives for the site.
  • Participate in the development and execution of qualification protocols for facility systems, manufacturing equipment, and laboratory instruments.
  • Assist in the identification, development, and implementation of new technologies to meet best practice expectations in the Manufacturing and Laboratory environments. Provide technical support for system owners and administrators for various facility systems, manufacturing equipment, and laboratory instruments.
  • Support the change control program with respect to facility and equipment changes. Support the Information Technology change control program for computerized systems.
  • Support the investigations program with respect to engineering, and qualification-related investigations, including trending and corrective and preventative actions.
  • Ensure audit readiness in areas of responsibility at all times. Act as a subject matter expert during internal, customer and regulatory-body audits. As directed and when needed, interact with auditors to explain and/or clarify policies, procedures, and examples of equipment and computerized validations.
  • Provide timely and effective completion of relevant activities in support of regulatory filings, production schedules and/or customer needs with respect to facilities, utility and equipment qualification.
  • Perform technical review of qualification-related documentation. Provide training/guidance to Maintenance/Engineering, Manufacturing, and Laboratory personnel on relevant policies and SOPs.
  • Collect and tabulate data, review data for errors and discrepancies, perform statistical analysis wherever appropriate and transcribe results into final reports.
  • Generate, review, and approve qualification/validation procedures.
  • Generate final reports, compile historical data packages, and route documents for approval.
  • Review and approve set-up and operation procedures for production and packaging equipment.
  • Generate risk assessments and technical memorandums to discuss the approach to qualification related activities.
  • Support the rationale for the sample size selection during process equipment qualification.
  • Review and complete assigned Change Control tasks.
  • Initiate and manage Non-conformances, Change Control and CAPA processes.
  • Participate/Perform Root Cause Analysis
  • Assess risks in process/product and propose mitigation steps (ISO14971)

FAQs

What is the primary purpose of the Advanced Quality Validation Engineer position at Bio-Techne?

The primary purpose of the Advanced Quality Validation Engineer position is to support qualification and validation activities for Manufacturing, Packaging equipment, and Facility and Utilities, ensuring compliance with regulatory standards and enhancing the quality of products.

What qualifications are required for this position?

A Bachelor’s Degree in Engineering, Life Sciences, or a related discipline is required, along with a minimum of 5-10 years of relevant experience in validation activities within a pharmaceutical or biotechnology environment, or an equivalent combination of education and experience.

What are some key responsibilities of the Advanced Quality Validation Engineer?

Key responsibilities include conducting validation studies, developing and reviewing qualification protocols, ensuring audit readiness, managing change control tasks, and generating final qualification reports.

What regulatory knowledge is preferred for applicants?

Applicants should have knowledge of current Good Manufacturing Practices (cGMPs), Annex 1, GAMP 5, 21 CFR Parts 210, 211, 11, as well as EudraLex - Volume 4 and WHO GMP guidelines.

What types of equipment and processes should candidates be familiar with?

Candidates should possess knowledge of process equipment, such as bioreactors, chromatography systems, and clean utilities, as well as a background in biological processes like fermentation and protein purification.

What skills are emphasized for this role?

Strong organizational and deductive reasoning skills, excellent communication and writing abilities, attention to detail, and proficiency in computer skills are emphasized for this role.

How does Bio-Techne support its employees' growth and development?

Bio-Techne fosters employee growth through mentorship, promotional opportunities, training and development programs, and internship initiatives, creating an environment conducive to career progression.

What benefits does Bio-Techne offer to its employees?

Bio-Techne provides competitive salaries, extensive medical, vision, and dental plans, 401k matching, stock purchase plans, and various employee resource groups and events to foster a culture of caring and belonging.

What role does the Advanced Quality Validation Engineer play during audits?

The engineer acts as a subject matter expert during internal, customer, and regulatory audits, providing explanations and clarifications regarding policies, procedures, and validation examples.

Is experience with software validation required for this role?

Yes, software validation experience is a preferred qualification for candidates applying for the Advanced Quality Validation Engineer position.

What is the company’s stance on diversity and equal opportunity?

Bio-Techne is committed to providing equal employment opportunities without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Bio-Techne

Science & Healthcare
Industry
1001-5000
Employees

Mission & Purpose

Bio-Techne Corporation (NASDAQ: TECH) is a leading developer and manufacturer of high-quality purified proteins and reagent solutions - notably cytokines and growth factors, antibodies, immunoassays, biologically active small molecule compounds, tissue culture reagents, and cell and gene therapy workflow solutions including T-Cell activation technologies. Bio-Techne’s portfolio also includes protein analysis solutions, sold under the ProteinSimple brand name, that offer researchers efficient and streamlined options for automated Western blot and multiplexed ELISA workflow. These reagent and protein analysis solutions are sold to biomedical researchers, as well as clinical research laboratories, and constitute the Protein Sciences Segment. Bio-Techne also develops and manufactures diagnostic products including FDA-regulated controls, calibrators, blood gas and clinical chemistry controls, and other reagents for OEM and clinical customers. Bio-Techne’s genomic tools include advanced tissue-based in situ hybridization assays (ISH) for research and clinical use, sold under the ACD brand, as well as a portfolio of clinical molecular diagnostic oncology assays including the ExoDx®Prostate (IntelliScore) test (EPI) for prostate cancer diagnosis. These diagnostic and genomic products comprise Bio-Techne’s Diagnostics and Genomics Segment. Bio-Techne products are integral components of scientific investigations into biological processes and molecular diagnostics, revealing the nature, diagnosis, etiology and progression of specific diseases. They aid in drug discovery efforts and provide the means for accurate clinical tests and diagnoses. With thousands of products in its portfolio, Bio-Techne generated approximately $714 million in net sales in fiscal 2019 and has over 2,200 employees worldwide.