Lead Operator, Manufacturing

4 settimane fa

Monza, Lombardia, Italia ThermoFisher Scientific A tempo pieno

Job Description

Thermo Fisher Scientific, a leading company in the field of Science, is in search of a Manufacturing Lead Operator for its PDS Business Unit.

The selected individual will work in a department where Visual Inspection, both semi-automatic and manual, of sterile medications in vials (liquid and lyophilized form) or pre-filled syringes is carried out.

The products to be inspected come from a customer portfolio that includes a mix of new pharmaceutical companies entering phase I/II/III clinical trials and big Pharma exploring new technologies (e.g. mRNA products), making the PDS production environment dynamic, stimulating, and focused on continuous improvement.

The Production Leader, reporting to the Visual Inspection Supervisor, will collaborate daily with the quality team and all other site functions to ensure customer satisfaction and deliver products to patients.

The lead will play a coordinating role in the assigned activities, ensuring timely collaboration of the operators.

Their contribution is crucial in terms of process and flow optimization.

POSITION PURPOSE/RESPONSIBILITIES:

Responsible for achieving quantity and quality objectives in the production activities of the PDS VI Department, through planning and control of departmental production activities on a daily and weekly basis, in accordance with company quality procedures and standards, safety regulations, environmental impact, and management directives.

SPECIFIC TASKS/PRIMARY ACTIVITIES:

Production Planning

  • Contributes to ensuring proper production planning weekly and daily, by assigning tasks to operators, respecting the budget and Planning directives.
  • Ensure production - including dedicated slots for validation/re-validation activities - in compliance with planned production quantities, timelines, and quality, through supervision of production activities, Batch Record control, department documentation related to tasks performed, in accordance with master batch records, customer requirements in terms of quantity, timelines, quality, GMP, company quality procedures and standards.
  • Support leadership in monitoring SOP application, ensuring compliance with master batch records, verifying process sampling, ensuring production data recorded complies with GMP and current procedures before submission to Quality Assurance, following company quality policies and procedures.

Cost Control

  • Support cost control and monitoring, in alignment with the assigned budget.
  • Support the Manager in ensuring correct implementation of activities related to chemical and microbiological sampling and documentation compilation, as per prevailing SOPs.

RELATIONSHIPS:

Internal

  • Planning
  • QA/QC pack
  • Maintenance
  • Engineering
  • Operators

REQUIREMENTS AND QUALIFICATIONS:

(A) ESSENTIAL

Education/Diplomas/Training Courses:

  • Degree in CTF, Chemistry, Chemical Engineering, or Diploma with experience

Technical and Computer Skills:

  • Knowledge of relevant software

Professional Experience:

  • Two years of experience for graduates
  • At least three years of experience in similar departments for Diploma holders

Languages:

  • English

Personality Traits:

  • Leadership
  • Management and coordination skills
  • Responsibility
  • Availability

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and upholds a commitment to diversity and inclusion, promoting a workplace that values individuals based on their skills and qualifications.

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