Senior Process Engineer

2 weeks ago

Albuquerque, New Mexico, United States curiate Full time


Job Overview:
The Senior Process Engineer will be responsible for overseeing and executing advanced engineering tasks within a dynamic environment. This role focuses on process design, scaling operations, and maintaining rigorous documentation standards.

This position requires collaboration with various teams, including Research and Development, Quality Assurance, and Production, to provide technical guidance and expertise aimed at enhancing process efficiency and ensuring adherence to industry regulations such as cGMP and FDA standards.

Key Responsibilities:
- Develop and maintain batch records tailored to specific client formulations and filling processes.
- Supervise processing operations, including equipment setup, bulk formulation, sterile filtration, and filling assistance, to facilitate process design and technology transfer.
- Serve as a Subject Matter Expert (SME) for GMP investigations, including CAPA and other compliance-related activities, while preparing closure reports for assigned engineering tasks.
- Engage in direct communication with clients to summarize engineering efforts both verbally and in writing, with support from senior engineers as necessary.
- Identify and specify equipment required for client technology transfers, developing techniques and parameters specific to client products while preserving essential product characteristics.
- Author operational instructions for equipment and detail process flows within cleanroom settings.
- Innovate new manufacturing processes to fulfill client needs while adhering to safety protocols.

Qualifications:
- Bachelor’s degree in Biology, Chemical Engineering, or a related discipline.
- A minimum of eight years of experience in a regulated cGMP/FDA environment, with a preference for experience in aseptic fill/finish operations.

Skills Required:
- Proficient in reading and interpreting technical documents, safety instructions, and regulatory guidelines.
- Strong written and verbal communication skills, along with effective presentation capabilities.
- Solid mathematical skills, including proficiency in arithmetic operations and a strong understanding of algebraic and geometric principles.

Reasoning and Computer Skills:
- Ability to analyze problems, gather data, and draw valid conclusions.
- Proficient in utilizing various software tools to enhance operational efficiency, including Microsoft Office Suite.

Physical and Work Environment:
- The role may require regular lifting and physical activity, with accommodations available for individuals with disabilities.
- Work environments may vary, including office, manufacturing, and warehouse settings, with necessary personal protective equipment required based on specific tasks.

Curia is committed to fostering an inclusive workplace where all qualified applicants receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status.

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