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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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