Job Description

Senior Process & Technology Specialist
Job Number: 21-06006
 
Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for a Senior Process & Technology Specialist for our client in Summit, NJ.
 
Eclaro’s client is a leader in the Biopharmaceutical Industry, providing quality, innovative, and affordable medicines that make a difference in the lives of patients all over the world. If you’re up to the challenge, then take a chance at this rewarding opportunity!
 
Position Overview:
  • Responsible for the solution design, on-site technical support, troubleshooting and problem resolution, recipe development and change management for the site manufacturing execution system and Enterprise Resource Planning (ERP) system.
  • Specialists work with IT, manufacturing, engineering, vendors and resources supporting boundary systems to deliver changes to recipes.
  • Works under the guidance of lead team members.
 
Responsibilities:
  • Responsible for providing manufacturing execution system operational support, documentation, recipe development, and change management.
  • Maintain MES library of objects and recipes utilized in Manufacturing.
  • Works with site functional teams, including manufacturing, engineering, warehouse and quality assurance to gather user requirements for recipe development.
  • Convert user requirements and paper Master Batch Records (MBRs) into MES electronic batch record (EBR) recipes.
  • Develop documentation to support the qualification of the MES recipes, including test scripts and functional specifications.
  • Execute testing of the recipes in the development environment to ensure functionality.
  • Manage User Acceptance Testing process for recipe qualification.
  • Develop and deliver reports from reporting software.
  • Adhere to GxP regulatory requirements and internal procedures.
  • Provide technical support by troubleshooting and resolving MES and ERP issues to support manufacturing operations.
  • Assist with department support model
 
Required Skills:
  • Advanced time management skills, including ability to prioritize and manage expectations
  • Advanced proficiency in Microsoft Excel & Visio
  • Advanced knowledge of manufacturing execution systems and ERP systems
  • Intermediate knowledge of qualification and validation requirements in a regulated environment
  • Intermediate knowledge of GMP manufacturing
  • Intermediate technical writing skills
  • Intermediate knowledge of crystal report design
  • Intermediate knowledge of SQL, VBA, and/or XML
  • Basic presentation development and delivery skills
  • Basic knowledge of cGMP regulations
  • Ability to perform Ad hoc database queries
  • Ability to provide accurate estimates and effectively communicate status of deliverables
  • Ability to gown into Grade C and D classified environments
  • Ability to provide on-call support in case of emergent issues
  • Ability to work independently for extended periods of time
  • Ability to work in a collaborative environment
 
Qualifications:
  • Bachelor's degree in a related field from an accredited college or university required.
  • Minimum of 5 years relevant work experience required, preferably in a pharmaceutical manufacturing environment.
  • An equivalent combination of education, experience and training may substitute.
  • Requires strong project management skills and coordination with stakeholders.
 
If hired, you will enjoy the following Eclaro Benefits:
  • 401k Retirement Savings Plan administered by Merrill Lynch
  • Commuter Check Pretax Commuter Benefits
  • Eligibility to purchase Medical, Dental & Vision Insurance through Eclaro
 
If interested, you may contact:
June Binuya
junethel.binuya@eclaro.com
2128047476
June Binuya | LinkedIn
 
Equal Opportunity Employer: Eclaro values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
 

Application Instructions

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