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Senior Process Engineering Specialist

2 months ago

Blue Ash, Ohio, United States Aprecia Pharmaceuticals Full time

Position Overview:


Join a dynamic team of engineers and scientists dedicated to the advancement and innovation of proprietary and non-proprietary processes within the pharmaceutical sector, particularly focusing on additive manufacturing technologies.

Your role will involve supporting the engineering and development of cutting-edge technologies, equipment, and material sets, ensuring that pharmaceutical product developers have access to a comprehensive and reproducible toolkit for the swift and confident development of commercially viable products.

Provide your expertise in process design, development, installation, and validation of Aprecia's proprietary 3D printing technology platforms.
Take charge of expanding and enhancing the technology platforms utilized in Aprecia's product development initiatives, which includes the creation of new processes and intellectual property.

Assist with general process requirements such as factory, site, and product acceptance testing of instruments, execution of design of experiments (DOE) or general testing protocols, and other facets of developing new or improving existing pharmaceutical manufacturing equipment aimed at commercial production or product development.

Generate and implement various engineering and validation documents associated with Aprecia's manufacturing equipment, ensuring our pharmaceutical products are produced with a focus on efficiency, safety, quality, and efficacy.


Key Responsibilities:
  1. Become a subject matter expert on Aprecia's advanced and legacy 3D printing manufacturing equipment.
  2. Lead initiatives for the development of automated equipment and processes, including the creation of operational and real-time testing concepts, documentation, specifications, risk assessments, design reviews, root cause analyses, and test plan generation and execution in collaboration with Design Engineering teams.
  3. Collaborate closely with Product Development, Technical Services, and Manufacturing teams to ensure that new and existing processes and technologies meet performance, flexibility, durability, reproducibility, and cost-effectiveness standards.
  4. Operate laboratory equipment to support the development of new printing fluids, product material characterization, alternative printing/process technologies, and process analytical technologies (PAT).
  5. Work with technology and integration vendors to ensure project specifications are met and delivered on schedule.
  6. Oversee the collection and statistical analysis of process data to define capabilities of new equipment, in-process testing, and critical process parameters (CPP) for continuous improvement.
  7. Draft and review technical memos, qualification/validation protocols, and reports to demonstrate control over the cleaning and manufacturing of drug products.
  8. Conduct sampling and testing as necessary based on established protocols or test plans to support validation activities.
  9. Prepare or review relevant documentation including change control documents, user requirement specifications (URS), scope of work documents, and operation/maintenance manuals for new or modified equipment.
  10. Manage projects as assigned for technical transfer and continuous improvement initiatives within Aprecia.

Reporting Structure:
No direct reports.

Travel Requirements:
This position may involve minimal travel.

Work Schedule:
This role operates during daytime hours.

Qualifications:
Proficient knowledge of the pharmaceutical industry and current Good Manufacturing Practices (cGMPs) is preferred.
Familiarity with additive manufacturing processes is advantageous.
Excellent written, verbal, and interpersonal communication skills are essential.
Strong abilities in statistical analysis, data management, and visualization are required.
Capability to work collaboratively across various disciplines within and outside the organization is necessary.
Experience with structured problem-solving tools and leading multidisciplinary teams in root cause analysis is desired.
Operational experience with Binder-Jet/Inkjet printing technology and powder bed additive manufacturing is a plus.
Project management and vendor management experience is beneficial.
Ability to manage multiple projects concurrently is crucial.
Adaptability to a fast-paced, advanced technology development environment is essential.
Mechanical/electrical assembly, wiring, and troubleshooting skills are advantageous.
Experience in machining, fabrication, or welding is a bonus.
Skills in PLC/Controls/Programming are also a plus.

Education and Experience:
A Bachelor’s degree in Engineering, Chemistry, Mathematics, or a related field is required.
A Master’s degree in Engineering, Chemistry, Mathematics, or a related field is preferred.
A minimum of 5-10 years of experience in the pharmaceutical or additive manufacturing industry, with a focus on developing novel equipment, processes, and technologies, is required.
Hands-on experience in operating, troubleshooting, testing, and improving manufacturing equipment is essential.

Physical Requirements:
Ability to read, interpret, and create technical materials with good eyesight.
Manual dexterity to operate computers and general office equipment is necessary.
Capability to sit or stand for extended periods.
Occasional lifting of materials (up to 25 pounds) may be required.
Ability to adopt various body positions for brief periods while conducting tests or validation work.
Compliance with personal protective equipment (PPE) requirements for pharmaceutical operations is necessary.

Company Commitment:


Aprecia Pharmaceuticals is committed to fostering a diverse and inclusive workplace. We are an equal opportunity employer and welcome applications from all qualified individuals without regard to race, color, religion, sex, age, genetic information, sexual orientation, gender identity, national origin, disability, or veteran status.