Manager, Process Support & Validation Execution
Celgene Corporation
Zofingen, Aargau CH
vor 1 Tg.

Description

Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives.

Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge.

With a presence in more than 70 countries, and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.

1. Competences

The post holder has the following competences in the area of Chemical Manufacturing Operations :

  • Keeps process documentation related to manufacturing, cleaning and campaign preparation up to date
  • Manages deviations, CAPA’s und change requests in his area of responsibility
  • Issues / revises operational and validation risk assessments related to EHS and GMP
  • Is responsible for the validation execution for manufacturing processes and equipment cleaning processes
  • 2. Skills / Knowledge Required

  • Education in Chemistry, Chemical Engineering or Life Sciences (Bachelor, Master an asset)
  • Familiar with GMP environment and has a strong quality understanding
  • Has at least 3 years of work experience in area of chemical manufacturing or process development
  • Is fluent in German, has very good knowledge in English
  • Has a basic understanding in statistics
  • Has an understanding in common risk assessment methodologies, is willing to continuously further develop his knowledge
  • Strong ability to take ownership and responsibility
  • Effective, competent communication style
  • Strong identification with Celgene’s values. Conveys them to team.
  • Experienced in common computer software (Windows, MS Office, etc.)
  • Ability to work in international cross-functional teams
  • Has efficient work style and is result oriented
  • 3. Duties and Responsibilities

    3.1 Process Support

  • Is author of records related to manufacturing processes, cleaning processes and campaign preparation processes
  • Initiates Change Request for updating records
  • Implements CAPAs related to process documentation
  • Supports the building supervisor in adhering to process instructions and SOPs
  • Ensures the presence of relevant data and documents (process, safety, quality) before starting production
  • Investigates deviations related to process, equipment, environment and product quality, is author of investigation reports
  • Defines and implements actions to reduce / prevent the occurrence of failed batches (in collaboration with QA functions).
  • Is responsible for campaign documentation and campaign evaluation (cGMP relevant data / critical process parameters and data collection for process optimization)
  • Requests support from the Manufacturing, Science and Technology department if needed
  • 3.2 Validation Execution

  • Oversees all manufacturing process and cleaning validation activities performed under the site validation master plan
  • Keeps the validation master plan up to date
  • Is author of process and cleaning validation documents and corresponding sampling plans
  • Supports Quality functions in writing of Product Quality Reviews and Annual Product Reviews with respect to process / quality data analysis and trending
  • Is the local SME for process and cleaning validation
  • Aligns validation activities with the Manufacturing, Science and Technology department
  • 3.3 Risk Assessment

  • Supports risk management in the quality and EHS area
  • Issues / moderates new risk assessments related to operational and validation activities
  • Reviews existing risk assessment based on defined intervals, updates existing risk assessment in case of needs
  • Trains himself, participates in courses and seminars related to risk management and risk assessment methodology (e.g. FMEA, PHA, HAZOP, etc.)
  • 3.4 Various Tasks

  • Supports reporting of KPI’s and metrics
  • Performs special tasks for the Associate Director, Manufacturing
  • Supports electronic and paper-based archiving of documents related to his role
  • The post holder informs his superior of extraordinary events in his area of activity
  • Demonstrates good collaboration with the Manufacturing, Science and Technology department
  • LI-POST

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