Lead Operator, Manufacturing Bardi

Lead Operator, Manufacturing
Bardi
Emilia Romagna, Bardi

Thermo Fisher Scientific, world leader in serving science, is looking for a Lead Operator, Manufacturing for its PDS Business Unit.

The resource will operate in a department where visual inspection, both semi-automatic and manual, of sterile drugs in vials (liquid and lyophilized forms) or pre-filled syringes is performed.

The products to be inspected come from a balanced portfolio of clients, including new pharmaceutical companies approaching phase I/II/III clinical studies and big pharma companies adopting 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 quality and all other site functions to achieve customer satisfaction and deliver products to patients.

The lead will coordinate the activities assigned to him/her, ensuring appropriate collaboration from operators.

His/her contribution is crucial in terms of process optimization and workflow.

Responsibilities Responsible for achieving quantity and quality objectives of production activities in the VI PDS department through planning and controlling production activities within daily and weekly timeframes, adhering to company quality procedures and standards, safety regulations, environmental impact considerations, and supervisor instructions. Production Planning: Contributes to ensuring proper production planning within the weekly and daily timeframe by assigning tasks to operators while respecting the budget and planning guidelines. Ensure production: Guarantees slots dedicated to validation/re-validation activities while respecting planned quantities, timelines, and quality standards through supervision of production activities, control of the Batch Record, and departmental documentation related to tasks performed, adhering to the master batch record, customer requirements in terms of quantity, timelines, quality, GMP, and company quality procedures and standards. Supports leadership in monitoring the application of SOPs by adhering to master batch record instructions, verifying process sampling, and ensuring that production data recorded complies with GMP and current procedures before submission to Quality Assurance, following company quality policies and procedures. Cost Control: Supports cost control and monitors performance against the assigned budget.

Assists the Manager in ensuring the proper execution of activities related to chemical and microbiological sampling and the compilation of relevant documentation as per current SOPs. Requirements Education: Degree in CTF, Chemistry, Chemical Engineering, or Diploma with experience. Technical and IT Knowledge: Familiarity with main software applications. Professional Experience: Two years of experience if graduated; at least three years of experience in similar departments if holding a diploma. Personality Traits: Leadership, management and coordination skills, responsibility, availability.

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