Validation Engineer II

KBI Biopharma•Boulder, CO

13d•Onsite

About The Position

Responsible for facilitating the validation lifecycle process for the Validation Department as a Level II resource to support cGMP manufacturing operations for biopharmaceutical products. 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, Computer System validation, Manufacturing process control system qualification, Cleaning validation, Steaming Validation, Air Visualization Studies, Mixing Studies. Staff will support technical decision making regarding validation strategies, projects, and change control requirements for effective implementation of validation strategies regarding the production of biopharmaceuticals in a multi-product facility. Staff member will coordinate and execute validation testing. Staff will make recommendations for changes and improvements and supports business efficiency improvement projects. Staff may be required to develop business cases and lead operational efficiency projects. Staff will own deviation, CAPA, and change control execution deliverables. Staff will be responsible for providing change control assessments. The staff member will work independently and as a member of a team (including matrixed organizational structures) and also work with external contractors to meet project needs and timelines.

Requirements

Minimum of Bachelor’s degree in a scientific or biochemical engineering discipline and five plus years experience supporting manufacture in a fermentation and/or cell culture environment along with a significant track record of accomplishments in meeting aggressive timelines or a Master’s degree.
Preferred skills of risk management and project management.
Knowledge of Quality Systems and cGMP requirements for multiple regulatory jurisdictions (FDA, EU, ICH) and the ability to effectively evaluate risk is preferred.
Demonstrated track record in the following key areas:
Strong orientation for quality and customer service to internal and external clients and have the ability to interface effectively with personnel across quality, engineering and other technical disciplines
Demonstrated level of respect for individuals and high level of integrity and personal responsibility
Ability to read and interpret technical documents (in the English language) such as schematic drawings, P&IDs, engineering specifications, safety rules, operating and maintenance instructions, procedure manuals, batch and production records.
Ability to write routine reports and correspondence on Facilities Eng/Val subject matter and speak effectively before internal groups or employees of organization.
Efficient and effective deductive and inductive critical thinking and problem-solving skills required and independently solve practical problems with minimal supervision and deal with a variety of concrete variables in situations where only limited standardization or data may exist.
Strong time management skills and an ability to multitask in a face paced environment.
Ability to quickly grasp complex technical concepts and to deliver consistent high-quality documentation paying attention to detail and thoroughness relative to SOP requirements.
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 and to utilize mathematical algorithms, formulas, physical constants, and data point measurements to demonstrate comparability and/or compliance with test acceptance criteria or performance specification criteria.
MS Office suite, Electronic Document/Info Management Systems, engineering software tools, MS Excel spreadsheet creation and data analysis functions.

Nice To Haves

Use of control system software
Use of statistical software

Responsibilities

Support drafting, execution, and review/approval of validation documentation, deviations, CAPAs, and change controls
Conform to all Quality System and cGMP requirements for documentation and data integrity
Support risk and impact assessments pertaining to engineering and pre-requisite support of validation work processes
Support the review of Engineering Specifications (URS, FRS, DDS, etc.)
Act as a supporting resource for operations support in execution of validation requirements, audit responses, and inspectional readiness
Support and/or lead business and operational excellence improvements and departmental initiatives
Assist with inspection preparation, project coordination and other related Validation tasks, as needed.