Process Engineer
Company: Astrix Technology Group
Location: College Station
Posted on: August 5, 2022
|
|
Job Description:
Hiring Immediately: Process EngineerBiotechnology Company -
College Station, TXM - F: 8am - 5pmThis 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 taking 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. Required
Knowledge/Technical Expertise Supporting single-use equipment and
systems such as: 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 Master s Degree with 6 years of relevant
experience; OR Bachelor s Degree with 8 years of relevant
experience; OR Associate s Degree with 10 years of relevant
experience. Preferred Qualifications: Experience in a GMP
environment. Degree in Engineering, Chemistry, Biology, Life
Sciences or related field.
Job Type: Full-timePay: $100,000.00 - $115,000.00 per yearBenefits:
Dental insurance Health insurance Relocation assistance Vision
insuranceSchedule: 8 hour shift Day shift Monday to FridayAbility
to commute/relocate: College Station, TX 77845: Reliably commute or
planning to relocate before starting work (Required)Application
Question(s): Do you have any experience with Depth Filtration
systems or Tangential Flow Filtration Systems? Do you have any
experience with Fermentation and/or Cell Culture reactors? Do you
have any experience with GE AKTA chromatography systems supported
by Unicorn software?Education: Bachelor's (Required)Experience:
CGMP: 3 years (Required)Work Location: One location
Keywords: Astrix Technology Group, College Station , Process Engineer, Engineering , College Station, Texas
Click
here to apply!
|