Assistant Engineer
Company: Tri-Pac Inc
Location: South Bend
Posted on: May 27, 2023
Job Description:
- - - - - - - - - - - - - - - - - - - - - - - - - - -Assistant
-EngineerTri-Pac, Inc. -a contract development and manufacturing
company (CDMO) specializing in -liquid and aerosol filling for
personal care and pharmaceutical marketers, is seeking an Assistant
-Engineer - -for immediate addition to our fast growing team. -Job
Description:The Assistant Engineer will demonstrate his/her
knowledge of biologics manufacturing processes, including
fermentation, purification, and bulk filling processes and work
independently in a team environment, influencing team decisions,
and exercising sound judgement in determining compliant and robust
validation approaches. - He/she will have the ability to multi-task
with a demonstrated track record in meeting deliverable timelines
and must demonstrate the ability to think critically and
analytically with acumen for troubleshooting and problem solving
and is a strong team player aligned with company corporate values.
- This individual will have good interpersonal, verbal, and written
communication skills and can function effectively and independently
in a fast-paced and dynamic environment. - He/she is self-motivated
and willing to tackle assignments and development opportunities
outside of job scope as needed. Demonstrates hands on experience
with facility/equipment/utility qualification, cleaning validation,
process validation, and sterilization validation experience in GMP
environment and with CIP/SIP cycle
development.Responsibilities:
Supports engineering activities, such
as creating Change Control, executing Validation documentation, and
writing Deviations.Provides support with writing technical
documents, Validation Summary Reports, and Change Control
closeouts.Works cross functionally with different departments to
gather technical information.Authors MPR-PCD Documents for
Regulated products.Participates with Cleaning validation activities
to collecting the cleaning samples.Participates in Internal and
External Audits.Supports with collection of data from vendors for
certifications.Scans the finished validation documents to archive
in Document Control.Execute the cleaning validation as per cleaning
validation protocol.Understands and documents cleaning/equipment
validation documents before execution.Performs validation and
quality activities.Collects Environmental and Compressed air
samples.Reviews all logbooks on daily/weekly basis and advises on
corrections.Supports general business tasks and follows up assigned
tasks with vendors, internal teams & customers.Prepares agendas and
records minutes for all internal meetings.Typing, compiling,
scanning and data entry.Organizing and updating project
trackers.Provides support for logging and shipments of customers
samples.Education and/or Experience:
Bachelor's Degree in Engineering or
Science discipline, with 0-2 years manufacturing
experience.Proficient in Microsoft Office (Word, Excel, PowerPoint
and Outlook)Experience with Statistics and Statistics
softwareBenefitsCompetitive Salary/ Pay & Packages, Vacations,
Insurance, 401K, Life Insurance, Disability (Long term/ Short term)
and Continuous Training. -Work where you are HAPPY! -Tri-Pac, Inc.
also recognizes the importance of continuing education and offers
Education Assistance to our employees to encourage continued
personal development and growth.www.tri-pac.usThank you for your
interest and consideration of a career with Tri-Pac, Inc.Tri-Pac,
Inc. is an Equal Employment Opportunity / Affirmative Action
EmployerTo Staffing & Recruitment Agencies: Our Company does not
accept unsolicited CV's or applications from agencies. We are not
responsible for any fees related to unsolicited CV's or
applications and explicitly reserve its right to contact candidates
presented in such unsolicited CV or application. -Powered by
JazzHR
Keywords: Tri-Pac Inc, South Bend , Assistant Engineer, Engineering , South Bend, Indiana
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