Position Summary
Responsible for facilitating the validation lifecycle process for the Validation Department as a Level I/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:
- Cleaning validation
- Facilities qualification
- Utilities qualification
- Equipment qualification
- Manufacturing process control system qualification
- Steaming Validation
- Air Visualization Studies
- Mixing Studies.
Position Responsibilities
Staff will support technical decision-making regarding validation strategies and requirements for projects and change controls. This position will support the effective implementation of validation strategies for the production of biopharmaceuticals in a multi-product facility. Additionally, this person will support the development of program-related strategy, documents, and SOPs. Staff members will coordinate and execute validation testing.
Staff will make recommendations for changes and improvements and support 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.
Staff members will be expected to provide exceptional customer service to internal and external clients. Staff must have the ability to interface effectively with personnel across quality, engineering, and other technical disciplines. The staff member must possess the ability to work independently, as a member of a team (including matrixed organizational structures), and to work with external contractors to meet project needs and timelines.
Additionally, staff may assist with inspection preparation, project coordination, and other related Validation tasks, as needed. Staff is expected to represent KBI and its programs with regulatory agencies as well as business partners.
Knowledge of Quality Systems and cGMP requirements for multiple regulatory jurisdictions (FDA, EU, ICH) and the ability to effectively evaluate risk is preferred.
- 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.
Work occasionally requires engineering studies and validation protocol execution to occur outside of 1st shift hours (8AM-5PM) to accommodate the availability of equipment/systems in support of the manufacturing schedule. This typically consists of off-shift work during planned shutdowns, regulatory inspections, and major capital project delivery.
Position Requirements
- Engineer I: Minimum of bachelor’s degree in a scientific, biochemical, or engineering discipline with 2 to 3 years of pharmaceutical experience
- Engineer II: Minimum of bachelor’s degree in a scientific, biochemical, or engineering discipline five plus years of pharmaceutical experience, or a master's degree and 3 years of experience.
- Experience with manufacturing biotechnology products in a fermentation and/or cell culture environment a plus
- A demonstrated track record in the following key areas: Strong orientation for quality and customer service, demonstrated level of respect for individuals, 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 Engineering /Validation subject matter
- Ability to speak effectively with internal and external stakeholders
- Efficient and effective deductive and inductive critical thinking and problem-solving skills
Salary
Validation Engineer I: $62,000-75,000
Validation Engineer II: $75,000-$90,000
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 has a robust total rewards strategy which includes an annual bonus structure for all employees, medical, dental, and vision coverage, paid PTO and holidays, Sabbatical program, 401K matching with 100% vesting in 60 days and employee recognition programs.
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 workforce. 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.
#J-18808-Ljbffr