9 days old

Process Engineer

Kelly Services
Durham, NC 27722
**_Process Engineer_**

**_Durham, NC_**

**_Direct Hire_**

**Client is open for years of experience-Must have Pharma or Biotech experience**

**Responsibilities will include:**

+ Develop plans, oversee, and execute engineering projects to improve manufacturing operations by implementing new processing equipment, facility designs and technologies at a company-wide level

+ Establish and maintain the procedures, business processes, SOPs and tools/systems for Process Engineering and associated manufacturing activities

+ Provide industry guidance and expertise for technical support of equipment modifications, deviations, change controls, and CAPAs

+ Maintain and document all cGMP equipment/system modifications and upgrades through approved change control methods. Creates and implements engineering policies, procedures, guidelines, and SOPs

+ Demonstrates a proficient understanding of equipment, instrumentation, and materials of construction to design, specify, procure, start-up, fully commission and troubleshoot equipment and systems

+ Provides hands-on support and execution for cGMP campaigns, including owning batch records for execution of unit operations, documenting all steps of the process and materials used for campaigns, initiating deviation investigations for complex upstream and downstream equipment / facility / system events

+ Lead complex investigational, root cause analysis efforts and provide immediate containments and preventative countermeasures. Implement corrective action plans and coordinate support in a timely manner

+ Lead collaboration on technical projects and/or studies with external partners (i.e. process development, vendors) and document in protocols, technical reports and/or presentations

+ Maintains ownership over the procedures, processes, and equipment for upstream and downstream drug s, and/or drug product fill and finish.

+ Provides technical guidance to tech transfer programs and personnel

**?Candidate must possess:**

+ BS in Biomedical, Chemical, or Biological Engineering, or a related field with pharmaceutical manufacturing experience (clinical manufacturing and/or licensed product manufacturing),

+ Must have demonstrated biologics expertise in upstream or downstream process engineering in a manufacturing environment that follows cGMP guidelines.

+ Must have experience with equipment and process troubleshooting in a biotechnology or pharmaceutical industry.

+ Must have experience leading root cause analysis investigations, identifying corrective and preventative actions, and implementing countermeasures. Lean Six Sigma green belt preferred, with any formalized training taken into consideration.

+ Experience with technical transfer and scale up is preferred.

+ Knowledge of clinical and commercial production operations is preferred.


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

Your engineering skills are in demand, but how do you find the right fit? Easy. With Kelly Engineering, our experts connect you with leading organizations where you can learn and grow, collaborate on innovative projects, and keep your skills sharp with top technology. Whether you prefer the variety and flexibility of short-term projects, or are looking for something more long-term, were here every step of the way to find your dream engineering job.

**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 and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.
Posted: 2021-09-10 Expires: 2021-10-11

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Process Engineer

Kelly Services
Durham, NC 27722

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