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Amphastar Pharmaceuticals Inc.

PTD Engineer

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Job Description

The Process Technology Development Engineer researches and evaluates new technology and design related to new equipment, process scale up and process improvement. Identify critical to quality attributes of the process and perform experiments to study the process control with the aim of optimizing the process at various stages in its product life cycle. Achieves the corporate target and ensure smooth process development and transfer for the commercial scale production. .
Responsibilities:
(Other duties may be assigned) Working with product pipelines at various stages of development Providing new technology and vendor evaluation and selection Working closely with other departments (i.e. NDRC, NTC and EC) and vendors to ensure process development project are progressing according to corporate plan Designing and performing experiments in the laboratories, pilot plants or manufacturing site to identify the critical to quality attributes of the process and establish appropriate process control Scaling up new manufacturing process and/or refining existing ones with the aim of optimizing the process and ensuring quality through the use of statistical tools and proven scientific methods Assessing manufacturing process capability and assisting with process variability reduction and process improvement initiatives as needed Preparing technical reports and specifications and maintaining appropriate records for process development projects to ensure smooth process technology transfer Education and/or
Experience:
Bachelor's degree (Bachelor of Science) from a four-year College or University in Chemical Engineering or other relevant scientific field. One to two years relevant working experience is a plus and familiarity with process control, pharmaceutical manufacturing process, and cGMP/GLP is preferred.
REASONING ABILITY
Able to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables. Able to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems. Able to design experimental study, collect and evaluate data to establish meaningful conclusion for process and technology evaluation. Able to think clearly and work with multiple projects at one time. Sunshine Act Amphastar reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Amphastar to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Amphastar intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Amphastar that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. EEO & Employment Eligibility Amphastar is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Amphastar also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Amphastar is an E-Verify employer. Amphastar is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Job Type:
Full-time Pay:
$31.00 - $35.00 per hour
Benefits:
401(k) 401(k) matching Dental insurance Health insurance Health savings account Life insurance Paid time off Referral program Retirement plan
Education:
Bachelor's (Preferred)
Work Location:
In person

Benefits

  • Paid Time Off (PTO)
  • 401(k) Plans
  • Other Retirement and Savings
  • Health Insurance