SouthBendRecruiter Since 2001
the smart solution for South Bend jobs

Validation Engineer

Company: Tri Pac, Inc.
Location: South Bend
Posted on: February 24, 2021

Job Description:

Tri-Pac, Inc. a contract development and manufacturing company (CDMO) specializing in liquid and aerosol filling for pharmaceutical marketers, is seeking an experienced Validation or Quality Engineer for immediate addition to our fast growing team. The position is in South Bend, Indiana.
Major Accountabilities:

  • Perform qualification of manufacturing equipment (liquid aseptic and aerosol aseptic), facility and utility systems (including CIP/SIP qualification), cleaning validation, and process validation. Scope of responsibilities includes drafting of qualification protocols and summary reports, field execution, and data analysis.
  • As needed coordinate and provide directions to contract personnel performing validation activities.
  • Support the development and execution of FATs, SATs, DQ, IQ, OQ, PQ, and other relevant life cycle documents leveraged to support validation effort.
  • Support the development and update of validation master plans, validation project plans, SOPs, risk assessments, user requirements, cleaning assessments, technical assessment reports.
  • Support cleaning and sterilization (including CIP/SIP, manual cleaning, steam sterilization) development activities.
  • Support periodic requalification and revalidation effort.
  • Work independently and directly interface with personnel from multiple departments including Technical Development, Manufacturing, Engineering, Manufacturing Support, MAC, QC, and QA..
  • Support gap assessment/closure, corrective actions, and compliance remediation related to Validation.
  • As needed represent Validation as SME (Subject Matter Expert) during regulatory or customer inspections.
  • As assigned mentor and manage fulltime validation engineers/specialist and contractors.
    Education:
    Minimum Bachelor's Degree in Engineering or Science discipline, advanced degree is a plus
    Experience:
    • Minimum 5+ years of relevant validation experience in regulated industry. The engineer is expected to be proficient in at least 3 of 7 validation core expertise.
    • Expertise in the following areas is must: Facility/Equipment/Utility Qualification, Cleaning/Sterilization Cycle Development, Cleaning Validation, and Process Validation.
    • Familiar with applicable domestic and international GMP regulations impacting validation requirements (e.g. 21 CFR 210,211,701,710,720,740, 820).
    • Familiar with current industry guidance documents impacting validation best practices (e.g. FDA Process Validation guidance, ISO 13485, and applicable PDA Technical Reports).
    • Experience with customer and regulatory inspection.
    • Strong understanding of quality risk management principles, including best practice in risk based C&Q approach.
    • Hands on validation experience in developing validation documentation and field execution.
    • Project Management experience is a plus
    • Aerosol production experience is a plus
      Skills:
      • Familiarity and demonstrated knowledge of biologics manufacturing processes, including fermentation, purification, and bulk filling processes.
      • Ability to work independently in a matrix team environment, influence team decisions, and exercise sound judgement in determining compliant and robust validation approach.
      • Ability to multi-task with demonstrated track records in meeting deliverable timelines.
      • Must demonstrate the ability to think critically and analytically with acumen for trouble-shooting and problem solving.
      • Good interpersonal skills, and accountable with excellent verbal and written communication skills.
      • Ability to function effectively and independently in a fast-paced and dynamic environment.
      • Self-motivated and willing to tackle assignments and development opportunities outside of job scope as needed.
      • Ability to interpret engineering and facility drawings such as facility layouts, blueprints, material/process flow diagrams, and equipment P&IDs.
      • Expert Microsoft Word / Powerpoint and Intermediate Microsoft Excel skills are required.
      • Understanding of basic statistics, acceptance sampling, and familiar with statistics software
      • Strong team player aligned with Grifols Corporate Values.
      • Hands on experience with facility/equipment/utility qualification, cleaning validation, process validation, and sterilization validation experience (steam sterilization and dry heat depyrogenation) in GMP environment is required.
      • Hands on experience with CIP/SIP cycle development and qualification is required
        Validation Core Expertise:
        • Facility Qualification
        • Equipment Qualification
        • Utilities Qualification
        • Cleaning Validation
        • Process Validation
        • Sterilization Validation
        • Computerized System Validation
          Benefits
          Competitive Salary/ Pay & Packages, 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.
          Thank you for your interest and consideration of a career with Tri-Pac, Inc.
          Tri-Pac, Inc. is an Equal Employment Opportunity / Affirmative Action Employer
          To Staffing and Recruiting Agencies: Our company does not accept unsolicited CVs or applications from agencies. We are not responsible for any fees related to unsolicited CVs or applications and explicitly reserve its right to contact candidates presented in such unsolicited CV or applicationIndustry

Keywords: Tri Pac, Inc., South Bend , Validation Engineer, Engineering , South Bend, Indiana

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Other Engineering Jobs


Mac Tools Seeking Mechanics - Automotive Technicians - Full Training
Description: Job title: Mac Tools Seeking Mechanics - Automotive Technicians - Full Training br br Job description: br br Build a Great Career and a Quality Life with Mac Tools. br br Feel the freedom (more...)
Company: Mac Tools
Location: Schererville
Posted on: 03/6/2021

Mac Tools Seeking Mechanics - Automotive Technicians - Full Training
Description: Job title: Mac Tools Seeking Mechanics - Automotive Technicians - Full Training br br Job description: br br Build a Great Career and a Quality Life with Mac Tools. br br Feel the freedom (more...)
Company: Mac Tools
Location: Oak Forest
Posted on: 03/6/2021

Satellite TV Technician - Paid Training
Description: DISH supports 135 In-Home Services facilities that deliver service solutions to customers in every zip code, across the entire country. The IHS organization encompasses thousands of talented and dedicated (more...)
Company: DISH
Location: New Lenox
Posted on: 03/6/2021


Mac Tools Seeking Mechanics - Automotive Technicians - Full Training
Description: Job title: Mac Tools Seeking Mechanics - Automotive Technicians - Full Training br br Job description: br br Build a Great Career and a Quality Life with Mac Tools. br br Feel the freedom (more...)
Company: Mac Tools
Location: South Holland
Posted on: 03/6/2021

Mac Tools Seeking Mechanics - Automotive Technicians - Full Training
Description: Job title: Mac Tools Seeking Mechanics - Automotive Technicians - Full Training br br Job description: br br Build a Great Career and a Quality Life with Mac Tools. br br Feel the freedom (more...)
Company: Mac Tools
Location: Lake Station
Posted on: 03/6/2021

IT Cloud Engineer IV
Description: CUNA Mutual Group br IT Cloud Engineer IV br CMFG Life Insurance Company is seeking an IT Cloud Engineer IV to be located primarily in the Chicago, IL metropolitan area, with occasional travel to (more...)
Company: CUNA Mutual Group
Location: Chicago
Posted on: 03/6/2021

Cortex Sales Engineer - SLED / Great Lakes Region
Description: Company DescriptionOur MissionAt Palo Alto Networks-- everything starts and ends with our mission:Being the cybersecurity partner of choice, protecting our digital way of life.We have the vision of a (more...)
Company: Palo Alto Networks
Location: Chicago
Posted on: 03/6/2021

Senior UI Engineer
Description: OneMain is the largest non-bank lender in the United States and a leading consumer finance company. br br One of our critical and highly visible initiatives is building and scaling industry-leading (more...)
Company: OneMain Financial
Location: Northbrook
Posted on: 03/6/2021

Cloud Data Engineer
Description: KellyMitchell matches the best IT and business talent with premier organizations nationwide. Our clients, ranging from Fortune 500 corporations to rapidly growing high-tech companies, are exceptionally (more...)
Company: KellyMitchell Group, Inc
Location: Chicago
Posted on: 03/6/2021

Senior Sales Engineer
Description: Company Description br br MicroStrategy transforms organizations into intelligent enterprises through data-driven innovation. We match smart people to dynamic projects and technologies that truly (more...)
Company: MicroStrategy
Location: Chicago
Posted on: 03/6/2021

Log In or Create An Account

Get the latest Indiana jobs by following @recnetIN on Twitter!

South Bend RSS job feeds