Job Details

HTI has an immediate opening for a Sr. Technical Services Scientist with a pharmaceutical manufacturer in Greenville, SC. The company offers a competitive benefits package and strong opportunities for growth and advancement. The salary range is approximately $105,000 - $120,000 / year, depending on experience. This is a direct-hire, full-time position and the working hours are Monday - Friday 8am-5pm. Relocation assistance is available for qualified candidates.

**Please note: This is not a lab or chemist role - pharmaceutical manufacturing plant experience is required

Requirements:

• Must have 6+ years of experience as a Technical Services Scientist or Process Engineer handling the job duties listed below at a

  pharmaceutical manufacturing plant.

• Must have experience with manufacturing processes for pharmaceutical products, including new product launch, scale-up, technology transfers, deviation investigations, and process validation.
• Must have a Bachelor's or Master's degree in Chemistry, Biology, Chemical Engineering, Mechanical Engineering, or a closely related area of study.
• Liquid dosage manufacturing experience is strongly preferred.
• Strong written and verbal communication skills.
• Must have technical writing experience, including

  writing/reviewing eCTD sections for FDA filings

  providing written justifications and answers to FDA information requests, as well as batch records, and reviewing/routing sub docs.
• Must be authorized to work in the United States without visa sponsorship.

Job summary:

This is a hands-on technical services/process engineering role, and this person will be on the manufacturing plant floor often, coordinating with other operations departments. The primary responsibility is to provide expertise in manufacturing process development, optimization and troubleshooting, batch size scale-up/down, and product transfer functions.

Job duties include:

• Lead technical services efforts during engineering, exhibit, and scale-up batch manufacture, engineering studies, equipment upgrades, etc.
• Provide technical expertise in identifying critical process parameters.
• Troubleshoot process and procedural issues; must be able to independently investigate and troubleshoot the manufacturing process and identify potential process optimization and improvements and provide timely effective resolution.
• Provide support to Packaging Engineer during investigations of deviations and variances in the packaging process.
• Generate investigation reports and propose/implement long-term corrective and preventative actions.
• Generate new/revise existing Master Batch Records (MBRs) for engineering, exhibit and commercial processes.
• Assist the Regulatory Affairs group with technical input. Generate and review eCTD sections as applicable to manufacturing and packaging processes to support FDA filings. Provide written justifications and answers to complete response letters and information requests from the FDA.
• Lead and provide the required support during technical process enhancements, including process and equipment validation, installation of new equipment, changes to existing manufacturing processes, etc.
• Identify and suggest process, equipment and efficiency improvements in the operational area.
• Prepare and present presentations for technical training of operations personnel.
• Review executed batch documentation.
• Collaborate with cross-functional groups to achieve project goals and meet timelines.
• Work in multi-functional teams with other departments (including Operations, R&D, PM, Validation, QA, QC, Engineering) to enhance and facilitate overall operational success.