Biopharmaceutical Validation Engineer

Boston, MA, United States
Mar 02, 2021
Lone Star Bio
Required Education
Bachelors Degree
Position Type
Full time

Commissioning and Validation support of the cleaning, equipment and process related to biopharmaceutical Manufacturing operations.
  • Provide technical support to site Validation personnel, as well as work with Engineering and QA to ensure reliable and predictable equipment and process operation.
  • Collaborate with multiple departments including Manufacturing, Facilities, Engineering, Quality Control, Validation, Quality Assurance, and Regulatory to facilitate agreement on equipment and process operational parameters, test requirements and acceptance criteria.
  • Own and Manage Change Controls to allow for the ongoing maintenance and optimization of Validated systems.
  • Generation, execution and closeout of Commissioning and Validation documentation, including test plans, procedures and protocols.
  • Review and approval of a variety of validation lifecycle documents, include but are not limited to validation and/or project plans, user requirement specifications, SOPs, maintenance documentation, investigation reports, deviation resolution, CAPA closeout, etc.
  • Support of cleaning development including bench-scale process simulation testing, CIP cycle development, visual and surface analysis and assessment of equipment cleanability.

Job Requirements
  • BS or MS degree in Science or Engineering
  • 2-5 Years relevant Industry experience
  • The temporary Validation Engineer II will provide leadership and technical support to Quality & Regulatory Compliance (QRC) and Manufacturing Operations staff on all aspects of the manufacturing and laboratory process controls.
  • Communicates current and applicable good manufacturing practices (GMP) and good laboratory practices (GLP) (e.g.: ISO13485 / 21 CFR Part 820 / CMDR) to business partners.
  • Executes functions needed to support change control activities and document management requirements.
  • Collaborates with business partners and peers to define validation and change control activity requirements for individual projects.
  • Establishes and communicates requirements for validation execution and documentation through daily interactions, training, and so on.
  • Assists and supports the development of equipment and process validations by participating in the design of feasibility studies that assess manufacturing capability / reliability.
  • Writes/revises or reviews /approves a variety of validation lifecycle documents. Document types include but are not limited to validation plans, validation protocols, equipment qualification (IQ/OQ/PQ), process validation, cleaning validations, requirement specifications, method validations, SOPs, work instructions and forms, investigations, validation deviations, CAPAs, any pertinent test data, and validation reports.

Key Requirements and Technology Experience
  • A minimum of a Bachelor's degree in Chemical or Mechanical Engineering, Chemistry, Biochemistry, and/or related discipline is required. Master's degree a plus.
  • A strong background in validation (and statistical tools such as Sampling Plans, Experimental Design and Optimization) is required.
  • Knowledge of current and applicable GMP regulations is required. Knowledge of FDA Quality System Regulations (QSR) and International Organization for Standardization (ISO) requirements and/or regulations is required.
  • Microsoft Office (Word, Excel, PowerPoint, etc.) tools experience for communications, reporting and data analysis is required.
  • Must be analytical, detail-oriented and able to interact with individuals of all levels.
  • Experience with Six Sigma/Process Excellence tools, training, and/or certification is preferred.
  • ASQ Certification or equivalent is preferred.