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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:
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 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.
Staff member 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.
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
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 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.
Full Time
Pharmaceutical
$91k-108k (estimate)
08/16/2024
10/15/2024
kbibiopharma.com
DURHAM, NC
500 - 1,000
1996
Private
TIMOTHY KELLY
$50M - $200M
Pharmaceutical
KBI Biopharma provides commercial cGMP manufacturing services for mammalian, microbial, and cell therapy programs.
The job skills required for Validation Engineer I/II include Problem Solving, Biotechnology, Change Control, Customer Service, etc. Having related job skills and expertise will give you an advantage when applying to be a Validation Engineer I/II. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Validation Engineer I/II. Select any job title you are interested in and start to search job requirements.
The following is the career advancement route for Validation Engineer I/II positions, which can be used as a reference in future career path planning. As a Validation Engineer I/II, it can be promoted into senior positions as a Validation Engineer III that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Validation Engineer I/II. You can explore the career advancement for a Validation Engineer I/II below and select your interested title to get hiring information.