Kuraray America, Inc.
Validation Engineer
Kuraray America, Inc., Thousand Oaks, California, United States, 91362
About USDM
USDM Life Sciences is a premier consulting company with 20+ years of experience assisting heavily regulated biotech, medical device, and pharmaceutical companies with their GxP technologies to accelerate growth. Our deep domain knowledge and technology expertise in life sciences business processes are what sets us apart. From strategy to implementation and adoption, we have delivered thousands of GxP projects globally.
As part of the USDM team, you have the opportunity to work with cutting edge technologies through our many partnerships with companies like Microsoft, Google, Oracle, DocuSign, Box, and many more. From molecule to market, you will help connect technology, people, and data in new ways to generate real-time insights to improve business outcomes for USDM’s clients. Are you ready to make an impact and drive real digital transformation in life sciences?
Founded in Santa Barbara in 1999, USDM has grown to a progressive, global company with 300+ remote employees and offices throughout the US, Canada, and Germany.
Nature and Scope of Job
USDM is seeking an experienced Validation Engineer to support the validation activities for the implementation of a new packaging line and updates to existing packaging lines.
Primary Responsibilities
Generate and/or support on the generation of lifecycle documentation, including but not limited to system/risk assessments, URS, specifications, etc. Route for approval lifecycle documentation.
Generate and route for approval Validation Plan, and Test Plan for the computerized systems.
Align Validation strategy with global strategy, as applicable.
Generate and route for approval the Test Scripts required for the computerized systems.
Execution and routing for post-approval of the Test Scripts required for the computerized/packaging systems.
Generate and route for approval of incidents/defects as a result of test scripts execution. Support engineering, DD&T and system owners in the incidents/defects resolution, and corrective actions.
Update lifecycle documentation as needed per incidents/defects result.
Generate and route for approval the Test Summary Report and Final Validation reports as required.
Maintain training current on relevant SOPs.
Daily accounting of time and activities submitted to Validation Lead/PM weekly.
Additional Responsibilities
Manage Tasks based on aggressive timelines.
Interact with customers at multiple sites.
Interact in team environment.
Qualifications
Experience with qualification of biologics/pharmaceutical computerized systems for manufacturing and/or Serialization Systems, and packaging lines.
Minimum 3 to 5 years in pharmaceutical industry, focusing on Validation. Thorough understanding of the principles of computer systems validation, SDLC methodologies and testing best practice. Knowledge of cGMP, GDP, GAMP, 21CFR Part11 and industry best practices. Ability to understand existing and new business processes and requirements to ensure proper implementation and validation of systems.
Strong technical background.
Strong communication and interpersonal skills ensuring the ability to interact with the business, peers and vendors in a professional manner. Ability to work independently with minimal supervision and adhere to timelines.
Quick learner.
Expert in MS Word.
Education & Certifications
University certificate or degree with a minimum of 5 years of related industry exp, or BS in Technology & 2-3 years of exp.
Working Conditions
The working conditions described here are representative of those that must be met by an employee to successfully perform the essential responsibilities and functions of the job, and are not meant to be all inclusive. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential responsibilities and functions of the job.
Unless reasonable accommodations can be made, while performing this job the staff member shall:
Prolonged periods of sitting or standing at a desk and working on a computer in an environmentally controlled home office environment.
Operate other office productivity machinery, such as a calculator, scanner, or printer.
Frequently communicate with stakeholders via telephone, email, or instant message. Must be able to exchange accurate information in these situations.
Equal Opportunity Statement
USDM Life Sciences is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Disclaimer
This job description is intended to describe the general nature and the level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. USDM Life Sciences reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.
Compensation
Base salary/hourly rate (W2): USD 75.00 – 85.00
The base salary/hourly rate range represents the anticipated low and high end of the USDM’s compensation range for this position. Actual salaries/hourly rates will vary and will be based on various factors, such as candidate’s qualifications, skills, competencies, and proficiency for the role. The compensation described above is subject to change and could be higher or lower than the range described based on market survey data or budget.
Full-time employees are eligible for health, vision, and dental insurance, life insurance, short and long-term disability, hospital indemnity, accident, and critical care coverage.
Both full and part-time employees, who are at least 21 years of age, are eligible to participate in USDM's 401k plan. Full and part-time employees may be eligible for paid time off.
All employees are eligible for USDM's rewards and recognition program.
For more details about our benefits, visit us here:
http://www.usdm.com/careers
#J-18808-Ljbffr
USDM Life Sciences is a premier consulting company with 20+ years of experience assisting heavily regulated biotech, medical device, and pharmaceutical companies with their GxP technologies to accelerate growth. Our deep domain knowledge and technology expertise in life sciences business processes are what sets us apart. From strategy to implementation and adoption, we have delivered thousands of GxP projects globally.
As part of the USDM team, you have the opportunity to work with cutting edge technologies through our many partnerships with companies like Microsoft, Google, Oracle, DocuSign, Box, and many more. From molecule to market, you will help connect technology, people, and data in new ways to generate real-time insights to improve business outcomes for USDM’s clients. Are you ready to make an impact and drive real digital transformation in life sciences?
Founded in Santa Barbara in 1999, USDM has grown to a progressive, global company with 300+ remote employees and offices throughout the US, Canada, and Germany.
Nature and Scope of Job
USDM is seeking an experienced Validation Engineer to support the validation activities for the implementation of a new packaging line and updates to existing packaging lines.
Primary Responsibilities
Generate and/or support on the generation of lifecycle documentation, including but not limited to system/risk assessments, URS, specifications, etc. Route for approval lifecycle documentation.
Generate and route for approval Validation Plan, and Test Plan for the computerized systems.
Align Validation strategy with global strategy, as applicable.
Generate and route for approval the Test Scripts required for the computerized systems.
Execution and routing for post-approval of the Test Scripts required for the computerized/packaging systems.
Generate and route for approval of incidents/defects as a result of test scripts execution. Support engineering, DD&T and system owners in the incidents/defects resolution, and corrective actions.
Update lifecycle documentation as needed per incidents/defects result.
Generate and route for approval the Test Summary Report and Final Validation reports as required.
Maintain training current on relevant SOPs.
Daily accounting of time and activities submitted to Validation Lead/PM weekly.
Additional Responsibilities
Manage Tasks based on aggressive timelines.
Interact with customers at multiple sites.
Interact in team environment.
Qualifications
Experience with qualification of biologics/pharmaceutical computerized systems for manufacturing and/or Serialization Systems, and packaging lines.
Minimum 3 to 5 years in pharmaceutical industry, focusing on Validation. Thorough understanding of the principles of computer systems validation, SDLC methodologies and testing best practice. Knowledge of cGMP, GDP, GAMP, 21CFR Part11 and industry best practices. Ability to understand existing and new business processes and requirements to ensure proper implementation and validation of systems.
Strong technical background.
Strong communication and interpersonal skills ensuring the ability to interact with the business, peers and vendors in a professional manner. Ability to work independently with minimal supervision and adhere to timelines.
Quick learner.
Expert in MS Word.
Education & Certifications
University certificate or degree with a minimum of 5 years of related industry exp, or BS in Technology & 2-3 years of exp.
Working Conditions
The working conditions described here are representative of those that must be met by an employee to successfully perform the essential responsibilities and functions of the job, and are not meant to be all inclusive. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential responsibilities and functions of the job.
Unless reasonable accommodations can be made, while performing this job the staff member shall:
Prolonged periods of sitting or standing at a desk and working on a computer in an environmentally controlled home office environment.
Operate other office productivity machinery, such as a calculator, scanner, or printer.
Frequently communicate with stakeholders via telephone, email, or instant message. Must be able to exchange accurate information in these situations.
Equal Opportunity Statement
USDM Life Sciences is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Disclaimer
This job description is intended to describe the general nature and the level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. USDM Life Sciences reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.
Compensation
Base salary/hourly rate (W2): USD 75.00 – 85.00
The base salary/hourly rate range represents the anticipated low and high end of the USDM’s compensation range for this position. Actual salaries/hourly rates will vary and will be based on various factors, such as candidate’s qualifications, skills, competencies, and proficiency for the role. The compensation described above is subject to change and could be higher or lower than the range described based on market survey data or budget.
Full-time employees are eligible for health, vision, and dental insurance, life insurance, short and long-term disability, hospital indemnity, accident, and critical care coverage.
Both full and part-time employees, who are at least 21 years of age, are eligible to participate in USDM's 401k plan. Full and part-time employees may be eligible for paid time off.
All employees are eligible for USDM's rewards and recognition program.
For more details about our benefits, visit us here:
http://www.usdm.com/careers
#J-18808-Ljbffr