Manufacturing Process Engineer
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Job Location:
Cincinnati, OH - USA
Monthly Salary:
Not Disclosed
Posted on:
2 days ago
Vacancies:
1 Vacancy
Job Summary
Work Schedule
Standard (Mon-Fri)Environmental Conditions
Office Some degree of PPE (Personal Protective Equipment) required (safety glasses gowning gloves lab coat ear plugs etc.)Job Description
Join our team as a Manufacturing Sciences Scientist II where youll contribute to ensuring consistent production of therapeutic and diagnostic products. As part of our Manufacturing Sciences team youll work at the intersection of research and production supporting process optimization technology transfer and continuous improvement initiatives. Youll collaborate with cross-functional teams to resolve technical challenges and ensure robust scalable manufacturing processes that meet quality standards.
As a Manufacturing Scientist II you will lead and/or implement activities for the development of new and established manufacturing processes of solids liquids and semi-solid dosage forms. Project management skills will be applied to implement the scaling up manufacturing processes supporting new product validations andpost approvalqualifications activities. This will requirethe writing approval and routing documents within a manufacturing setting.
You will be the primary technical representative on client projects and will workclosely workwith internal and external project teams of analytical quality and project management representatives. Supporting process development and commercial activities will be. Leads technical/scientific project activities and discussions to lead strategies and technical solutions that meet client needs and expectations.
Investigates creates andvalidatesnew scientific and equipment methodologies for a diverse scope of projects. Using experimental designestablishedformulation processes for the following phases of product scale-up registration and validation.
Creates processes and equipment design for clinical scale up and/or registration batches including technology transfer of projects to and from clients. Leads problem solving activities as necessary with independent judgement. Makes decisions that require choosing between multiple options or may develop new options to resolve moderately complex problems.
REQUIREMENTS:
Advanced Degree with no prior experience required OR Bachelors Degree plus 2 years of experience in GMP manufacturing process development or related technical role
Preferred Fields of Study: Bachelors degree in chemical engineering (or other engineering field) chemistry pharmacy or other related science or technical field is.
Minimum of one (1) to three (3) years of experience in a manufacturing environment (preferred). Experience in product or process development including scale-up and technology transfer processes for both immediate and controlledreleasedosage forms preferred.
Strong understanding of cGMP requirements regulatory compliance and quality systems
Experience with process validation technology transfer and scale-up activities
Strong project management and documentation skills
Excellent written and verbal communication abilities
Ability to work independently and collaboratively in a dynamic environment
Demonstrated problem-solving and troubleshooting capabilities
Proficient with Microsoft Office Suite and relevant manufacturing/quality systems
Experience with risk assessment and root cause analysis
Ability to train and support team members
May require occasional weekend/off-hours support
Must be able to wear required PPE and work in controlled environments
Physical requirements include ability to lift up to 35 lbs and stand for extended periods
Additional language skills beneficial
Required Experience:
IC
Key Skills
- Lean Manufacturing
- Six Sigma
- CNC Programming
- Lean
- Machining
- Tooling
- CAD
- CNC
- Assembly Experience
- SolidWorks
- Kaizen
- Manufacturing
About Company
Electron microscopes reveal hidden wonders that are smaller than the human eye can see. They fire electrons and create images, magnifying micrometer and nanometer structures by up to ten million times, providing a spectacular level of detail, even allowing researchers to view single a ... View more
