Job Title: Process Engineer Pharmaceutical Manufacturing
Location: Ohio 100% Onsite
Duration: 6 Months Contract
Rate: $45 - $52/hr W2
Experience: 5+ Years
Position Overview:
Seeking Process Engineers to support pharmaceutical process scale-up, technology transfer, process validation, and commercial manufacturing readiness for a portfolio of small-molecule products. The ideal candidates will have strong experience in pharmaceutical process validation, technology transfer, scale-up activities, manufacturing support, and batch documentation. The engineers will serve as technical leads across development-to-commercialization activities and work closely with Manufacturing, Quality, Process Development, and external partners.
Key Responsibilities:
- Lead pharmaceutical process scale-up and technology transfer activities
- Support process validation activities for commercial manufacturing
- Provide technical support during manufacturing campaigns and product launches
- Develop and review manufacturing batch records and process documentation
- Support development-to-commercialization activities for small-molecule products
- Partner with Manufacturing, Quality, Development, and external technical teams
- Identify process risks and develop appropriate mitigation strategies
- Support process improvements, CAPAs, and lifecycle management activities
- Analyze process data and support troubleshooting and root-cause investigations
- Provide technical guidance during product launches and manufacturing readiness activities
- Support validation campaigns and ensure successful execution of manufacturing processes
- Maintain appropriate technical documentation and ensure alignment with quality requirements
- Manage multiple projects and priorities in a fast-paced pharmaceutical manufacturing environment
Required / Preferred Qualifications:
- Bachelor's degree in Engineering, Chemistry, Pharmacy, or a related scientific discipline required
- 5+ years of relevant experience in pharmaceutical process engineering, process development, validation, or manufacturing support
- Strong experience with pharmaceutical process validation
- Experience with technology transfer and process scale-up activities
- Experience supporting manufacturing operations and commercial manufacturing readiness
- Experience with batch record development and manufacturing documentation
- Strong problem-solving, analytical, leadership, and communication skills
- Ability to work independently and manage multiple priorities in a fast-paced environment
- Experience with oral solid dosage forms and/or liquid pharmaceutical products is preferred
- Small-molecule pharmaceutical manufacturing experience is preferred
- Experience with Minitab or statistical analysis is a plus
- Experience supporting commercial product launches is a plus
- Experience with process improvements, CAPAs, and lifecycle management is preferred