Technical Services Scientist (Pharmaceutical manufacturing)

HTI; Greenville (SC); On-site; USD 80,000 - 110,000; Full time

Job summary

A pharmaceutical manufacturer in Greenville, SC is looking for a Technical Services Scientist or Process Engineer. This full-time role involves hands-on process engineering on the manufacturing plant floor, focusing on manufacturing process development and troubleshooting. The ideal candidate has strong experience with pharmaceutical manufacturing processes and must possess a relevant Bachelor's or Master's degree.

Qualifications

• 3+ years of experience as a Technical Services Scientist or Process Engineer in pharmaceutical manufacturing.
• Experience with manufacturing processes for pharmaceutical products.
• Liquid oral dosage manufacturing experience.

Responsibilities

• Lead technical services during engineering and batch manufacture.
• Troubleshoot manufacturing process and identify optimizations.
• Generate investigation reports and long-term corrective actions.

Skills

Manufacturing process development

Technical writing

Strong communication skills

Education

Bachelor’s or Master’s degree in Chemistry, Biology, Chemical Engineering, Mechanical Engineering

Job description

Overview

HTI has an immediate opening for a Technical Services Scientist or Process Engineer with a pharmaceutical manufacturer in Greenville, SC. The salary range is $80,000 - $110,000 per year, depending on experience. This is a direct-hire, full-time position with Monday - Friday 8am-5pm and relocation assistance available.

This is not a chemist or laboratory position. Candidates must have manufacturing process development experience in the pharmaceutical manufacturing industry.

Base pay range

$80,000.00/yr - $110,000.00/yr

Requirements

• Must have 3+ years of experience as a Technical Services Scientist or Process Engineer with a pharmaceutical manufacturing plant, handling the duties listed below.
• 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 and/or Master’s degree in Chemistry, Biology, Chemical Engineering, Mechanical Engineering, or a closely related area of study.
• Must have liquid oral dosage manufacturing experience.
• Strong written and verbal communication skills.
• Must have technical writing experience.
• Must be authorized to work in the United States without visa sponsorship (now or in the future).

Job summary

This is a hands-on 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

• 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.

Employment type

• Full-time

Job function

• Science and Engineering

Industries

• Pharmaceutical Manufacturing and Manufacturing

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