Manufacturing Process Engineer

Thermo Fisher Scientific•Cincinnati, OH

About The Position

Join our team as a Manufacturing Sciences Scientist II, where you'll contribute to ensuring consistent production of therapeutic and diagnostic products. As part of our Manufacturing Sciences team, you'll work at the intersection of research and production, supporting process optimization, technology transfer, and continuous improvement initiatives. You'll 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 and post approval qualifications activities. This will require the writing, approval, and routing documents within a manufacturing setting. You will be the primary technical representative on client projects and will work closely work with internal and external project teams of analytical, quality, and project management representatives. Supporting process development and commercial activities will be required. Leads technical/scientific project activities and discussions to lead strategies and technical solutions that meet client needs and expectations. Investigates, creates, and validates new scientific and equipment methodologies for a diverse scope of projects. Using experimental design, established formulation 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 Bachelor's Degree plus 2 years of experience in GMP manufacturing, process development, or related technical role
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

Nice To Haves

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 controlled release dosage forms preferred.
Preferred Fields of Study: Bachelor's degree in chemical engineering (or other engineering field), chemistry, pharmacy, or other related science or technical field is required.
Additional language skills beneficial

Responsibilities

Lead and/or implement activities for the development of new and established manufacturing processes of solids, liquids, and semi-solid dosage forms.
Apply project management skills to implement the scaling up manufacturing processes, supporting new product validations and post approval qualifications activities.
Write, approve, and route documents within a manufacturing setting.
Serve as the primary technical representative on client projects, working closely with internal and external project teams of analytical, quality, and project management representatives.
Support process development and commercial activities.
Lead technical/scientific project activities and discussions to lead strategies and technical solutions that meet client needs and expectations.
Investigate, create, and validate new scientific and equipment methodologies for a diverse scope of projects.
Use experimental design, established formulation processes for the following phases of product scale-up, registration, and validation.
Create processes and equipment design for clinical, scale up, and/or registration batches, including technology transfer of projects to and from clients.
Lead problem solving activities as necessary with independent judgement.
Make decisions that require choosing between multiple options or may develop new options to resolve moderately complex problems.