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Manufacturing Process Engineer
On-site · Cincinnati, Ohio, United States
Job Summary
Manufacturing Sciences Scientist II for process optimization, technology transfer, and scale-up of solid, liquid, and semi-solid dosage forms within GMP manufacturing setting. Lead development and transfer activities, conduct experimental design, validate processes, and prepare documentation for regulatory/commercial batches while coordinating with analytical, QA, and project-management teams. Requires strong GMP knowledge, project management, written/verbal communication, and ability to work independently in a fast-paced environment while wearing PPE.
Required Qualifications
- 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
- 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
- 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
- Education Bachelor’s degree in chemical engineering (or other engineering field), chemistry, pharmacy, or other related science or technical field is required
- Experience Minimum of one (1) to three (3) years of experience in a manufacturing environment
- Experience in product or process development, including scale-up and technology transfer processes for both immediate and controlled release dosage forms preferred
- Project Management experience with a minimum (1) year of experience
- Knowledge, Skills, Abilities Understanding of GMP and regulatory compliance
- Lead projects of moderate to high complexity in scope and compliance-related challenges
- Proficiency using MS Office applications
- Strong communication and leadership abilities
- Ability to work in fast-paced, results-oriented environment
- Coordinate and lead weekly meetings with customers
- Ability to stand, walk, stoop, kneel, crouch, lift 10-35 pounds
- Vison, dexterity, and coordination for typing and equipment operation
- Written communication skills expected and presentation will be expected
- Equal Opportunity Employer
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