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Special Process Validation Technician (H/F)

Permanent contract

Domalain near Rennes

Presentation

Peters Surgical, a French company, develops, produces and markets sterile single-use medical devices for the operating room and intended for surgeons.

As a European leader in medical devices, we have more than 750 employees worldwide. Our international dimension allows us to distribute our products in more than 90 countries.

As part of its CSR policy and aware of climate issues, Peters Surgical is voluntarily committed to a sustainable development approach in order to reduce its impact on the environment.

Joining Peters Surgical means integrating a dynamic structure and participating in the development of a company in full expansion. In this capacity, we are looking for a:

Special Process Validation Technician

 

Reporting to the Group Validation Director based at one of our production sites in Domalain (35). Near Rennes, the Domalain production site is located in a welcoming region, offering a good quality of life and benefiting from a dynamic employment pool.

You are responsible for managing the validation of special processes, in particular processes validated with our suppliers, subcontractors and service providers. You ensure that validations are carried out, control of maintaining the validated state and monitoring according to regulatory requirements.

Join Peters Surgical and participate in the development of our group in a flexible and inclusive working environment, based on trust and respect.

Description of missions

  1. In this context your missions will be:
    • Work in partnership with the purchasing department and the service providers implementing these processes in order to obtain the data necessary to demonstrate the conformity of process validations and support service providers in improving validation files.
    • Collect, analyze, validate, organize supplier documentation “special processes” QI/QO/QP based on internal requirements.
    • Participate in updating supplier specifications.
    • Write validation plans/protocols/validation reports if necessary.
    • Implement tests if necessary to complete these validations.
    • Establish associated monitoring plans.
    • Manage technical audits of supplier processes.
    • All internal/external validation topics (in support or in engine)

Skills

You have good interpersonal skills, your practical mind and your taste for the field will allow you to work closely with the relevant departments of the various manufacturing sites and suppliers. ,You have a facility for writing technical documents (French and English) and you have the capacity for adaptability, versatility and openness to change.,You are recognized for your rigor, your sense of organization and your ability to analyze and synthesize.

Your profile
  • Experience:
    You have solid experience in process validation in a demanding environment within industries, ideally medical devices.
  • Training:
    BAC + 3 (Validation Specialty)
  • Languages:
    English
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