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28 days old

Process Development Engineer

Kelly Services
Lexington, KY 40508
**Job Title: Process Development Engineer**


**Location: Lexington, KY**


**Work-Type: Direct-hire, On-site (1st shift M-F), Full-time**


**Job Description:**

The Process Development Engineer is responsible for performing and/or leading a wide-array of manufacturing process/equipment development and engineering activities in a pharmaceutical cGMP environment. These activities include designing and leading studies to support process development. Writing/executing/summarizing protocols for testing equipment, product and processes. Also assists in troubleshooting, equipment and facility design, and cleaning/process validation.


**Requirements:**


+ Bachelors degree in engineering (or equivalent experience)

+ 3+ years of pharmaceutical process or pharmaceutical manufacturing engineering experience

+ Strong attention to detail


_Preferred_


+ Strong verbal communication and technical writing skills

+ Able to work collaboratively with manager, peers, and cross-functional project teams

+ Excellent knowledge of cGMP and regulatory requirements


**Essential Duties:**


+ Lead projects or participate on project teams to develop the manufacturing process for new products and implement improvements to existing processes for the manufacture of nasal spray drug products

+ Engage with the Pharmaceutical Development Group in all stages of product/process development to facilitate successful transfer of activities to the commercial manufacturing environment

+ Design and execute studies as required to investigate, optimize, troubleshoot, and implement process improvements

+ Work on multiple process development and validation projects simultaneously and coordinate work with various other departments

+ Participate in the development and implementation of procedural or automationimprovement changes

+ Write procedures, protocols and reports for manufacturing and cleaning/processvalidation

+ Compile validation packages and assure all required documentation is accurate and complete

+ Champion process improvement projects and ensure equipment and systems remain in a qualified state

+ Lead investigations and assure thoroughness of investigation, identification of root cause, documentation and closure

+ Participate in design reviews of plant expansions or process changes, and serve as a technical point of contact or user representative for contract services

+ Provide support to Manufacturing, Quality, Maintenance, and Validation for deviation investigations, change controls and CAPAs through participation on cross functional teams

+ Lead risk assessment exercises related to equipment and processes, including Failure Mode Effect Analysis (FMEA).

+ Train technicians on Production Batch Records.

+ Assist or conduct investigations to resolve deviations, including Root Cause Analysis (RCA).

+ Other duties as assigned


**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.


**Why Kelly** **** **?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)
Posted: 2022-07-18 Expires: 2022-09-05

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Process Development Engineer

Kelly Services
Lexington, KY 40508

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