Amphastar Pharmaceuticals, Inc. · 3 months ago
Manufacturing Process Engineer
Amphastar Pharmaceuticals Inc. is seeking a Manufacturing Process Engineer to support activities of pharmaceutical production and ensure compliance with policies and regulations. The role involves researching and evaluating technology related to existing and new processes, preparing manufacturing procedures, and coordinating activities between different departments.
BiotechnologyManufacturingMedical
Responsibilities
Work closely with other departments (i.e. Pipeline, Engineering, Validations, and Clinical departments) to ensure projects are progressing according to corporate plan
Assess manufacturing process capabilities and assist with process variability reduction and improvement initiatives as necessary
Support relevant Engineering activities for current or developmental manufacturing processes and equipment
Advise management, technical personnel, and representatives of other organization of activities
Assist in the preparation and review of production related reports and procedures
Conduct investigations relating to manufacturing non-conformances and implement effective corrective and preventative actions
Initiate change controls for critical changes relating to the manufacturing processes, drug products, the equipment and the manufacturing facility
Prepare relevant manufacturing regulatory submission documentation for new products
Qualification
Required
Bachelor's degree (B.S.) from four-year college or university in Chemical engineering or other relevant scientific field
Clear understanding of process control, pharmaceutical manufacturing processes, and cGMP
Attention to details and awareness of surroundings
Effective time management skills
Awareness of cGMPs and SOPs
Ability to use small hand tools such as: screwdrivers, nutdrivers, wrenches and allen wrenches
Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry
Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations
Preferred
Bachelor's (Preferred)
Benefits
401(k)
401(k) matching
Dental insurance
Health insurance
Health savings account
Life insurance
Paid time off
Referral program
Retirement plan
Company
Amphastar Pharmaceuticals, Inc.
Amphastar Pharmaceuticals is a recognized pharmaceutical company that uses state-of-the-art, cGMP-compliant facilities to develop, manufacture, and market biopharmaceutical injectable, intranasal, and inhalation products.
H1B Sponsorship
Amphastar Pharmaceuticals, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (6)
2024 (2)
2023 (5)
2022 (6)
2021 (6)
2020 (9)
Funding
Current Stage
Public CompanyTotal Funding
$300M2023-09-13Post Ipo Debt· $300M
2014-06-25IPO
Recent News
2026-01-12
Company data provided by crunchbase