Sr. Process Engineer - College Station
Company: Kelly Services
Posted on: April 9, 2021
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
- 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
- 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
- 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
- Fermentation and Cell Culture reactors
- GE AKTA chromatography systems supported by Unicorn
- Tangential Flow Filtration Systems
- Depth Filtration systems
- Working within cGMP environments in relation to biologics and
- Process development or manufacturing experience with clinical
- 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
- Effectively communicates results of own work through meetings,
presentations, discussions and documentation with some input from
- Minimum supervision required on day-to-day activities and
- Ability to work in a team-oriented environment is essential, as
this person will work closely with other team members and
- Self-motivated and capable of demonstrating technical
- Excellent interpersonal communication skills and ability to
influence and collaborate in a team environment.
- Analytical and excellent problem-solving skills.Minimum
- PhD with 1 year of relevant experience; OR
- Master's Degree with 6 years of relevant experience; OR
- Bachelor's Degree with 8 years of relevant experience; OR
- Associate degree with 10 years of relevant experience.Preferred
- 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, we're here every step of the way to find
your dream engineering job.About Kelly--At Kelly, we're always
thinking about what's next and advising job seekers on new ways of
working to reach their full potential. In fact, we're a leading
advocate for temporary/non-traditional workstyles, because we
believe they allow flexibility and tremendous growth opportunities
that enable a better way to work and live. 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.]]
Keywords: Kelly Services, Bryan , Sr. Process Engineer - College Station, Engineering , Bryan, Texas
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