1+ months

Sr. Process Engineer - College Station

Kelly Services
College Station, TX 77840
The Senior Engineer functions independently and productively within a team-based organization to actively address complex cGMP manufacturing issues. The individual is responsible for analyzing process technologies in support of new project proposals and takes responsibility for the technical transfer into the manufacturing group. This individual must work in a collaborative manner coordinating the transfer of biological drug processes from process development (internal or client) groups in a CMO environment.

**Essential Functions:**

+ Applies scientific and cGMP manufacturing expertise to research and resolve issues in the technology transfer and implementation of client specified manufacturing processes for biologics including viral based products and vaccines.

+ Leads multiple overlapping cross-functional technology transfer teams that include client technical staff and internal process development and manufacturing teams. Will also be responsible for assisting other teams as SME.

+ Research and recommend single-use process equipment of appropriate scale and quality for the cGMP execution of client specified manufacturing processes.

+ Responsible for the preparation of user requirements, vendor quotes, and purchasing of equipment as well as supporting capital projects by providing technical expertise.

+ Oversees and leads small complex engineering projects.

+ Assist in overseeing contractor activities, as required.

+ Provides technical information for the preparation of change controls, protocols, and new user training for the process equipment.

+ Reviews process requirements for GMP manufacturing through process specifications and batch records.

+ Identifies raw materials and consumables of appropriate quality for the cGMP execution of client specified manufacturing processes; assists in the preparation of material specifications, vendor quotes, and the purchase of the materials.

+ Responds to client and/or internal staff questions or concerns about cGMP equipment, materials, and procedures.

+ Uses key and critical process parameters and their associated critical quality attributes to assist in the preparation of product specifications.

+ Provides data analysis from each manufacturing run that will be included in intermediate and final project summary reports and other team deliverables.

+ Contributes to and ensures the achievement of goals and tech transfer milestones on multiple projects without delay in schedule or excessive use of resources.

+ Perform all other duties as assigned.

**Required Knowledge/Technical Expertise**

+ Fermentation and Cell Culture reactors

+ GE AKTA chromatography systems supported by Unicorn software

+ Tangential Flow Filtration Systems

+ Depth Filtration systems

+ Working within cGMP environments in relation to biologics and vaccine manufacturing.

+ Process development or manufacturing experience with clinical scale projects.

+ Single-use manufacturing equipment and materials.

+ Understanding and experience in aseptic techniques.

+ Document writing including protocols, batch records, and SOPs and summary reports.

+ Using Microsoft Excel, Word, and PowerPoint.

**Other Abilities:**

+ Demonstrated credibility by performing high quality work.

+ Coaching and mentoring less experienced team members.

+ Expand the technical capabilities of teams using academic and hands-on experience.

+ Effectively communicates results of own work through meetings, presentations, discussions and documentation with some input from supervisor.

+ Minimum supervision required on day-to-day activities and accomplished tasks.

+ Ability to work in a team-oriented environment is essential, as this person will work closely with other team members and clients.

+ Self-motivated and capable of demonstrating technical competence.

+ Excellent interpersonal communication skills and ability to influence and collaborate in a team environment.

+ Analytical and excellent problem-solving skills.

**Minimum Qualifications:**

+ PhD with 1 year of relevant experience; OR

+ Masters Degree with 6 years of relevant experience; OR

+ Bachelors Degree with 8 years of relevant experience; OR

+ Associate degree with 10 years of relevant experience.

**Preferred Qualifications:**

+ Experience in a GMP environment.

+ Degree in Engineering, Chemistry, Biology, Life Sciences, or related field.

**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: 2021-03-08 Expires: 2021-04-26

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Sr. Process Engineer - College Station

Kelly Services
College Station, TX 77840

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