Plant Project Engineer - API

Posted 5 Days Ago
Be an Early Applicant
Ceriano Laghetto, Monza e Brianza, ITA
In-Office
42K-42K Annually
Mid level
Biotech • Pharmaceutical
The Role
Manage CAPEX projects for an API manufacturing site from feasibility through handover, coordinating SMEs, contractors and procurement; ensure compliance with cGMP, PED/ATEX and ISO standards; oversee P&ID updates, equipment procurement, commissioning (IQ/OQ/PQ), cost control and documentation transfer.
Summary Generated by Built In

Contract type:

Permanent

Bracco is an international Group active in the healthcare sector and a leader in diagnostic imaging. The Group’s main products are contrast agents sold in over 100 countries, both directly and indirectly through branches, joint ventures and license and distribution agreements.

Within the organization of Global Technical Operations / Site Engineering Team, the Project Engineer will be assigned to Plant Projects in API manufacturing site, supporting all the aspects related to Capex Project execution.

Activities and Responsibilities

  • Manage assigned Capex projects throughout all phases: feasibility studies for time and cost estimation, project presentation for budget/GANTT approval, execution phases including preparation of technical specifications, preparation/update of P&IDs, procurement of equipment and materials, preparation of mechanical, electro-instrumental and software tender documents, plant construction, final testing and handovers to requesting departments;

  • Cooperate with internal subject matter experts (SMEs) and with other plant functions (Production, HSE, Maintenance, Automation, Quality, Regulatory, etc.) to guarantee project delivery within deadlines, monitoring costs to ensure budget compliance, in compliance with up-to-date technical standard, company policies and adhering to national/EU regulations (e.g., PED, ATEX), and quality standards (cGMP, ISO 9001, ISO 14001, OHSAS 18001/ISO 45001).

  • Coordinate external engineering companies and oversee external contractors ensuring adherence to legislative, contractual and technical regulations in the development of assigned projects;

  • Provide periodic reports regarding on-going and completed activities, economic final balances and project progress status;

  • Update and transfer project documentation to the site's technical archive during execution phases;

  • Issue and track purchase requests (PRs), manage vendor relations, draft purchase specifications and verify material compliance upon arrival;

  • Coordinate testing and qualification (IQ/OQ/PQ) of new installations;

  • Collaborate with the Maintenance Department on small-scale modifications, plant improvements and utility optimization.

Professional / technical knowledge

  • Strong knowledge of plant engineering design within the chemical-pharmaceutical sector.

  • Skilled in interpreting technical documentation, including PFD, P&IDs, plant layouts and sections, civil engineering drawings and detailed machinery and equipment detailed specifications.

  • Knowledge of applicable technical regulations and Good Engineering Practices.

  • Practical experience with GMP-compliant plant commissioning and qualification within chemical-pharmaceutical environments.

  • Experience with procurement and relevant management systems (e.g. SAP).

  • Familiarity with workplace safety regulations.

  • Proven expertise in budgeting, cost control and Project Management methodologies to ensure project viability.

  • Experience with industrial automation and process control systems.

  • Fluent English and Italian

Education and Professional Experience

  • MSc Degree in Chemical Engineering

  • At least 4 years of experience in an equivalent role within API production plants (preferred) or an Engineering Company.

Interpersonal Skills

  • Proactive approach / problem solving

  • Coordination attitude

  • Commitment to goals achievement and competence sharing

  • Positive behavior towards changes

  • Communication skills

Employment Terms

The role is classified at Level B under the National Collective Agreement for the Chemical-Pharmaceutical Industry (CCNL Chimico-Farmaceutico). The guaranteed minimum base annual gross salary established by the CCNL for the applicable level is € 41.575,24.

The overall compensation will be determined based on the experience, skills, and qualifications of the selected candidate.

If you meet the requirements of this opportunity and would like to join an international group working to improve patients' lives, apply now!

At Bracco, we believe in the values of diversity and inclusion. We respect and celebrate the diversity of our people and their experiences, ensuring a fair opportunity for all.

We are #Bracco #JoinUs

Skills Required

  • MSc Degree in Chemical Engineering
  • At least 4 years of experience in API production plants or engineering companies
  • Strong knowledge of plant engineering design within the chemical-pharmaceutical sector
  • Skilled in interpreting PFDs, P&IDs, plant layouts, civil drawings and equipment specifications
  • Practical experience with GMP-compliant plant commissioning and qualification (IQ/OQ/PQ)
  • Experience with procurement and management systems (e.g., SAP)
  • Knowledge of applicable technical regulations and Good Engineering Practices (PED, ATEX)
  • Experience with industrial automation and process control systems
  • Proven expertise in budgeting, cost control and Project Management methodologies
  • Familiarity with workplace safety regulations and quality standards (ISO 9001, ISO 14001, OHSAS 18001/ISO 45001)
  • Fluent English and Italian
  • Proactive problem solving, coordination, communication and change adaptability
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The Company
HQ: Milano, Milan
1,975 Employees

What We Do

Bracco is an international Group active in the healthcare sector and a leader in diagnostic imaging. It has around 3,700 employees and annual total consolidated revenues of around 1,7 billion euros, 89% of which from international sales. In the R&D area, the company invests approximately 10% of reference turnover in the imaging diagnostics and medical devices sectors. The Group’s main products are contrast agents, medical substances used to improve the diagnostic accuracy of biomedical imaging and the care of patients affected by diseases of varying type and severity. Bracco offers an extensive and innovative portfolio of products and solutions for all diagnostic modalities completed by several medical devices and advanced administration systems for contrast imaging products in the fields of cardiology and radiology, developed by it’s American company ACIST. Since its foundation, Bracco has been a socially responsible company in each area of activity - in business as in every other context. Its subsidiary Bracco Imaging is one of the world’s leading companies in the diagnostic imaging field :X-Ray Imaging (including Computed Tomography-CT), Magnetic Resonance Imaging (MRI), Contrast Enhanced Ultrasound, and Nuclear Medicine. The Company operates in over 110 markets: in North America through Bracco Diagnostics Inc. USA , and with an affiliate in Montreal (Canada); in Europe, with offices in all major countries; in Japan (BRACCO-EISAI). The Company also operates in South America, South Korea and China through its 70% controlled Joint Venture, Bracco Sine Pharmaceutical Corp. Ltd.

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