Process Engineer IV jobs in United States
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Curia · 6 hours ago

Process Engineer IV

Curia is a global contract development and manufacturing organization (CDMO) with over 30 years of experience partnering with pharmaceutical and biotech companies to provide life-saving treatments to patients. The Process Engineer IV will execute and oversee advanced engineering functions such as process design, scale-up, and meticulous documentation control, collaborating closely with cross-functional teams to drive process improvements and ensure compliance with industry standards.

BiotechnologyHealth CareManufacturing
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H1B Sponsor Likelynote
Hiring Manager
Hang Nguyen
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Responsibilities

Develop batch records for client-specific formulation and filling operations. Oversee processing operations (ENG and GMP) including equipment preparation, bulk product formulation, sterile filtration, and filling support, to facilitate process design and internal technology transfer
With senior/managerial engineering support, operate as an SME for GMP investigations (e.g. CAPA, departures, CCRs) as well as finalize closure reports for departures that are assigned to process engineering. Direct client interaction for routine discussions, summarizing engineering-related work completed verbally as well as written. Client communication will be supported by more senior-level engineers, as needed
Identify and specify process-specific equipment needed for clients’ tech transfer, and develop techniques and process parameters specific to the client's product while maintaining critical product attributes. Author instructions for the operation of equipment and for detailing process flows in the cleanroom facility
Develop new manufacturing processes to meet client requirements. Adhere to safety requirements at all times. Raise deviations in the process to the attention of the shift supervisor, engineering manager, and/or quality assurance

Qualification

CGMP/FDA experienceProcess designAseptic fill/finishManufacturing softwareTechnical documentationMathematical skillsCommunication skillsProblem-solving skills

Required

Bachelor's degree in Biology, Chemical Engineering, or a related field
Minimum eight (8) years' experience in a cGMP/FDA, regulated environment
Must pass a background check
Must pass a drug screen
May be required to pass Occupational Health Screening
May be required to obtain and maintain gowning certification
May be required to obtain and maintain media qualification
May be required to wear a respirator
Ability to read and interpret various documents including safety instructions, standard operating procedures, technical procedures, and governmental regulations
Strong written and verbal communication skills
Effective presentation skills
Proficient in executing arithmetic operations including addition, subtraction, multiplication, and division across various units of measurement
Strong grasp of algebraic and geometric principles
Ability to define problems, collect data, establish facts, and draw valid conclusions
Ability to interpret an extensive variety of technical instructions in mathematical or diagram form
Strong technical foundation and proven capability in effectively utilizing diverse software tools
Adeptness in manufacturing and internet software
Proficiency in Microsoft Office tools including PowerPoint, Excel, Word, and Outlook

Preferred

Experience with aseptic fill/finish

Benefits

Generous benefit options (eligible first day of employment)
Paid training, vacation and holidays (vacation accrual begins on first day of employment)
Career advancement opportunities
Education reimbursement
401k program
Learning platform
And more!

Company

Curia is a biotechnology company that offers discovery biology, synthetic, medicinal chemistry, and small-scale manufacturing services.

H1B Sponsorship

Curia 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 (34)
2024 (17)
2023 (8)

Funding

Current Stage
Late Stage
Total Funding
unknown
2025-03-07Debt Financing
2017-08-31Private Equity

Leadership Team

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Steve Lavezoli
Vice President, Biologics Division
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Company data provided by crunchbase