Process Engineer II

Build your future at Curia, where our work has the power to save lives

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. At Curia, we are on a mission to advance our customers’ therapies from curiosity to cure and ultimately to improve patients’ lives.

We proudly offer

• Generous benefit options (eligible first day of employment)
• Paid training, vacation and holidays (vacation accrual begins on first day of employment)
• 401K program with matching contributions
• Learning platform
• And more!

Summary:

The Process Engineer II is responsible for facilitating the technology transfer of client processes and executing engineering functions including design, scale‑up, documentation. This role functions as a program lead with direction from the functional group leadership. The Engineer provides guidance and instruction to supporting team members on tasks directly related to their project, in addition to providing training for new team members

Essential Duties and Responsibilities:

• Develops batch records and leads process activities for client‑specific formulation and filling operations for at least one client. Oversees critical operations (ENG and GMP) including equipment preparation, bulk product formulation, sterile filtration, and filling support
• Acts as an SME for GMP investigations (CAPA, departures, CCRs) from initiation to closure
• Finalizes closure reports for the 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 based on facility, client, and program needs. Author instructions for the operation of equipment and for detailing process flows in the cleanroom facility
• Develop new procedures to meet facility and client requirements
• Adhere to safety requirements at all times
• Designs and provides training on operation tasks, like those captured in SOPs or work instructions
• Provides training on client programs and processes
• Professionally communicate deviations to the appropriate leaders involved in the production process
• Read/interpret SOPs to ensure compliance
• Maintain up to date trainings
• Other duties as assigned

Education and Experience:

• Bachelor’s degree in Biology, Chemical Engineering, or related field of study
• Minimum of three (3) years’ experience in Pharmaceutical, Biotech or related industry
• Minimum of three (3) years’ experience process engineering work experience
• 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, such as safety instructions, standard operating procedures, technical procedures, and governmental regulations.

Additionally, they should possess strong written and verbal communication skills, along with 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 to streamline the organization's daily functions. Essential skills encompass adeptness in manufacturing and internet software, alongside proficiency in Microsoft Office tools including PowerPoint, Excel, Word, and Outlook.

Other

Skills and Abilities:

• P…