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Global Process Validation Engineer

Date: 14-Nov-2021

Location: Gothenburg, SE Havirov, CZ Waremme, BE Oldham, GB Mikkeli, FI Karvina, CZ

Company: Mölnlycke Health Care

WORKING AT MÖLNLYCKE 

Are you looking for a great career and want to make your mark?  

Please keep on reading but don’t just take our word for it. We’ve interviewed colleagues around the world about their jobs, the Mölnlycke unique culture and Mölnlycke people and it is simply A great company to work for! 

Could you help improve healthcare outcomes around the world? 

If the answer is yes, you think just like us and should apply for this exciting opportunity that we have below. 

 

We are currently recruiting for a Global Process Validation Engineer.

In this role you will:

  • Ensure compliance with applicable process validation requirements and good practices for our internal and external manufacturing sites
  • Support development and continuous improvements of manufacturing processes based on statistical techniques or tools
  • Contribute and monitor required process validations
  • Support implementation and continuous improvement of process risk procedures and processes within the organization

 

Key Accountabilities:

  • Function as a process validation and equipment qualification subject matter expert
  • Support the implementation and maintain adequate global validation processes to ensure product safety and compliance in our internal  and external manufacturing sites
  • Contribute and monitor required validations based on external and internal requirements
  • Contribute to projects and can be the validation representative
  • Participates in CAPA, FMEA and other failure investigation activities related to process validation and process risk management
  • Conduct validation training and qualify personnel conducting validation activities.

 

Key Decisions:

  • Review and approve validation documentation
  • Decide on actions to be taken in order to comply with validation requirements
  • Decide on qualification processes needed, determine what tools and processes are suitable for Mölnlycke operations for Process Validation and Process risk management
  • Decide if a proposed action is adequate to handle nonconformity or improvement.
  • Decide on actions to fulfill the necessary project requirements and objectives.

 

Capabilities, Qualifications and Experience:

 

  • Knowledge of ISO 13485; FDA QSR 820, ISO 14971, ISO 11607 series
  • Knowledge of statistical methodologies
  • Good team-working and communication skills
  • Planning and coordination skills is a plus
  • Ability to adapt to changes in priorities and project schedules.
  • English written and spoken
  • Masters’ degree preferably
  • A minimum of 5-10 years Manufacturing and / or QA experience in the Medical Devices/Pharma industry with significant expertise in Validation .
  • 3-5 years’ experience in writing and reviewing process validation / equipment qualification
  • Experience from work in an international organization or environment is a plus
  • International travels  10 to 40%
  • The role could be located anywhere in EU and will belong to corporate organization.

 

About Mölnlycke

Mölnlycke is a world-leading medical solutions company. We design and supply solutions to enhance performance at every point of care – from the hospital to the home proven it every day.

We specialise in:

•Wound management: including dressings with Safetac® such as Mepitel® and Mepilex®

•Preventing pressure ulcers: with Mepilex® Border used prophylactically and devices to help turn    and re-position patients

•Surgical solutions: including Mölnlycke trays, HiBi® antiseptics and Biogel® surgical gloves

Mölnlycke was founded in 1849. Nowadays our solutions are available in around 100 countries; we’re the number one global provider of advanced wound care and single-use surgical products; and we’re Europe’s largest provider of customised trays. Our headquarters are in Gothenburg, Sweden and we have about 7,800 employees around the world.