Process Engineer IV
Curia
Summary
The Process Engineer IV will execute and oversee advanced engineering functions such as process design, scale-up, and meticulous documentation control. This position will collaborate closely with cross-functional teams, including R&D, Quality Assurance, and Production, providing technical leadership and expertise to drive process improvements, enhance operational efficiency, and ensure compliance with industry standards such as cGMP and FDA regulations.
Job description
Summary
The Process Engineer IV will execute and oversee advanced engineering functions such as process design, scale-up, and meticulous documentation control. This position will collaborate closely with cross-functional teams, including R&D, Quality Assurance, and Production, providing technical leadership and expertise to drive process improvements, enhance operational efficiency, and ensure compliance with industry standards such as cGMP and FDA regulations.
Essential Duties and 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.
- 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.
Education and/or Experience
- Bachelor's degree in Biology, Chemical Engineering, or a related field with minimum eight (8) years' experience in a cGMP/FDA, regulated environment OR Master's degree in Biology, Chemical Engineering, or a related field with minimum six (6) years' experience in a cGMP/FDA, regulated environment
- Experience with aseptic fill/finish, preferred
Supervisory Responsibilities
This role does not have supervisory responsibilities, yet it may involve mentoring, guiding, and advising.
Language Skills
The ideal candidate should have the ability to read and interpret various documents including safety instructions, standard operating procedures, technical procedures, and governmental regulations. Additionally, the candidate should possess strong written and verbal communication skills and effective presentation skills.
Mathematical Skills
Proficient in executing arithmetic operations including addition, subtraction, multiplication, and division across various units of measurement, employing whole numbers, fractions, decimals, and percentages. Candidates must possess a strong grasp of algebraic and geometric principles.
Reasoning Ability
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 and deal with several abstract and concrete variables.
Computer Skills
The ideal candidate will possess a strong technical foundation and proven capability in effectively utilizing diverse software tools. Essential skills encompass adeptness in manufacturing and internet software, alongside proficiency in Microsoft Office tools including PowerPoint, Excel, Word, and Outlook.
Other Qualifications
- 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
Requirements
- Bachelor's degree in Biology, Chemical Engineering, or a related field with minimum eight (8) years' experience in a cGMP/FDA, regulated environment OR Master's degree in Biology, Chemical Engineering, or a related field with minimum six (6) years' experience in a cGMP/FDA, regulated environment
- Experience with aseptic fill/finish, preferred
- Ability to read and interpret safety instructions, standard operating procedures, technical procedures, and governmental regulations
- Strong written and verbal communication skills
- Effective presentation skills
- Proficient in arithmetic operations and strong grasp of algebraic and geometric principles
- Ability to define problems, collect data, establish facts, and draw valid conclusions
- Proficiency in Microsoft Office tools including PowerPoint, Excel, Word, and Outlook
- 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
Benefits
- Generous benefit options
- Paid training
- Paid vacation
- Paid holidays
- Career advancement opportunities
- Education reimbursement
- 401(k) program
- Learning platform
Company overview
Curia is a leading global Contract Development and Manufacturing Organization (CDMO) with over 30 years of experience in the pharmaceutical industry. Headquartered in Albany, New York, the company operates an integrated network of 25 global sites across North America, Europe, and Asia, employing approximately 3,500 professionals. Curia provides comprehensive end-to-end solutions spanning drug discovery, development, and manufacturing services for both small molecules and biologics. Their expertise covers active pharmaceutical ingredient (API) manufacturing, sterile drug product development, analytical testing, and regulatory support. The company specializes in complex areas including high-potency compounds, controlled substances, sterile APIs, and mRNA manufacturing. With state-of-the-art GMP facilities and a strong focus on innovation, Curia partners with pharmaceutical and biotechnology companies to accelerate the development and commercialization of life-changing therapeutics, from early-stage discovery through commercial-scale production.