Major Accountabilities

• Guarantee the correct operation of the equipment, systems, plants present in the production site through the coordination of all the Technical activities, carried out by internal and external resources

• Coordinate the technical activities on the equipment / systems as improvement projects and upgrade projects on the same ones

• Support the production activities participating in the multi-department workshops and projects

• Guarantee the Aseptic process compliance (by equipment upgrade) and Aseptic Process improvement

• Collaborate with MS&T and Production department to understand better their needs and processes for systems compliance, efficiency, and reliability (evaluating needs for upgrade or substitution)

• Accountability and/or responsibility for the GMP documentation both external and internal

• Improvement of the qualification, validation and other GMP / technical documentation adapting it to the corporate standards

• Execute qualification (and sometimes) validation activities or coordinate external resources in the execution under own accountability

• Support the process of Continuous Improvement and Compliance for aseptic processes

• Support eCompliance improvement projects

• Guarantee the safety of internal and external resources working on the equipment, in accordance with applicable normative and corporate procedures (through the implementation of preventive measures).

• Participate in the technical investigations on the GMP deviations on the site production systems and processes

Key Performance Indicators

Active collaboration in multi-department teams to guarantee:

• Compliance of the production processes (by equipment and systems compliance)

• Execution of the Production planning (by efficiency and reliability of the equipment)

• GMP compliance and eCompliance of the equipment and systems (by respecting maintenance, calibration, and requalification plans)

• HSE performance indicators (safety as principal)

• Qualification and Validation of the new equipment or systems respecting scheduling and budget of the Investment projects

• Requalification and Revalidation of the existing equipment / systems up to Validation Activity Schedule (yearly qualification / validation plan) – on time

• Execution of the Site Quality Plan

Job Dimensions

Subordinate Functions: None

Number of Associates: Direct: 0; Indirect: 2-3

Financial responsibility (where appropriate): N/A

Impact on the organisation (where appropriate): High.

Efficiency and Reliability of the equipment as well

as GMP Compliance and eCompliance is

necessary pre-requirement to guarantee:

- Product quality

- Production planning

- Quality Plan respect

Ideal Background (State the minimum and desirable education and experience level)

Education: Batchelor Degree In Engineering (5 years) – preferably electrical or mechanical

Languages: Fluent English spoken and written. Basic Knowledge of the Pharmaceutical and Technical terminology in English

Skills (and Experiences) desired:

•  5-year Direct experience in Pharmaceutical companies or Consultant Companies for Pharmaceutical industry

• Direct experience in managing pharmaceutical equipment (maintenance, calibration, requalification) with particular attention to Aseptic processes (sterilisation, depyrogenation, freeze drying, aseptic filling, WFI loops, …)

• Direct experience and knowledge of GMP documentation (Risk Assesment, Change Request/Management, Root cause analysis, Statistical analysis of production and performance indicators)

• Direct experience in preparation of the GMP documentation for pharmaceutical equipment

• Direct Experience in handling the projects for upgrade or substitution of the existing pharmaceutical equipment

• Direct experience in management (definition, follow-up) of budget for the equipment investments

• Direct experience in management and coordination of external contractors and consultants