h3Validation Equipment Compliance Manager /h3 pDate: 2 Oct **** /p pDepartment: Quality Operations Italy, Parma Site /p pBusiness Area: Quality /p pJob Type: Direct Employee /p pContract Type: Permanent /p pLocation: Parma, IT /p pbAbout us /b /p pChiesi is an international research-focused biopharmaceutical group with 90 years' experience, operating in more than 30 countries, with its Headquarter in Parma, Italy.
More than 8,000 employees across the group are united by a singular purpose: promoting a healthier world for our people, patients, and the planet.
This is what drives us as we research, develop, and market innovative drugs across our main therapeutic areas.
Discover more here.
/p pAt Chiesi we are thinking generations ahead, driving sustainable innovation with purpose.
This fosters a culture of reliability, transparency, and ethical behaviour at every level.
As a Benefit Corporation and a certified B Corp, we have embedded sustainability in our bylaws and continuously measure our impact.
/p pDiversity and inclusion are at the heart of who we are.
We believe our differences make us stronger.
We are a vibrant ecosystem of passionate, talented individuals united by strong values, each bringing unique perspectives that help us to continuously challenge the status quo for the better.
/p pbGlobal Technical Operations Supply /b /p pGlobal Technical Operations Supply (Global TechOpS) is Chiesi's global manufacturing and supply area, responsible for ensuring consistent, outstanding quality, service and value across our end?to?end supply chain.
Global TechOpS oversees the entire lifecycle of the drug: from process optimization and industrialization, to manufacturing, engineering, quality oversight, and supply chain management.
Throughout this journey, Operational Excellence drives continuous improvement.
This end?to?end model is powered by our four manufacturing sites - Parma (IT), Blois (FR), Santana de Parnaíba (BR), and Nerviano (IT) - together with our Virtual Plant network of external partners.
/p h3This is what you will do /h3 ul liProvide Quality oversight and formal approval for qualification and validation activities in full compliance with applicable regulatory requirements and guidelines.
Lead and control the site Validation Program, covering equipment, processes, utilities, facilities, computerized systems, cleaning procedures, and laboratory instruments, ensuring that products consistently perform as intended and meet predefined quality standards.
/li liEnsure regulatory and GMP compliance in the management of validation and qualification processes, including oversight of manufacturing and laboratory equipment throughout their lifecycle.
/li liGuarantee Data Integrity compliance across all site computerized systems by ensuring proper execution and governance of Computerized System Validation (CSV) activities.
The scope applies to all GMP areas of the site and extends across both Active Pharmaceutical Ingredient (API) and Finished Product manufacturing operations.
/li /ul h3You will be responsible for /h3 pKey Responsibilities /p ul liSupport the Quality Management in defining, allocating, and monitoring the budget related to departmental projects and initiatives.
/li liContribute to workforce planning by assessing required FTEs and identifying necessary competencies.
/li liDefine and maintain the internal organizational structure, including roles, responsibilities, and job assignments.
/li liSet and assign qualitative and performance objectives in alignment with the company's MBO system.
/li liPromote team development through tailored training plans and coaching programs based on individual needs.
/li liEnsure that managed personnel remain aligned with corporate competency frameworks and organizational behaviors.
/li liMonitor adherence to company values, code of conduct, ethical standards, and applicable legal and contractual requirements.
/li /ul pPeople Management Operational Oversight /p ul liManage personnel in compliance with labor laws, contractual obligations,



and workplace health and safety regulations; plan and coordinate team activities and support issue resolution.
/li liEnsure operational efficiency and safety of departments, facilities, and equipment by planning and overseeing required maintenance activities and implementing actions to minimize health and safety risks.
/li liPropose necessary investments to maintain safety, compliance, and operational effectiveness.
/li /ul pHealth, Safety Compliance /p ul liEnsure fulfillment of mandatory information, training, and employee instruction obligations in accordance with applicable health and safety regulations.
/li liCollaborate with the EHS Department in the preparation and update of the departmental Risk Assessment Document (DVR).
/li liImplement and oversee risk control measures, including emergency procedures and evacuation protocols in case of serious and imminent danger.
/li liVerify proper use and adequacy of collective protective measures and personal protective equipment (DPI), ensuring timely replacement when necessary.
/li liPromptly report to the employer any irregularities or situations that may pose potential health and safety risks.
/li /ul h3You will need to have /h3 ul liBachelor's or Master's Degree in a scientific or engineering discipline (e.g., Chemistry, Pharmaceutical Chemistry and Technology, Engineering).
/li liMinimum 8–10 years of experience in pharmaceutical or biopharmaceutical manufacturing environments, within Engineering, Production, Process Technology, QA Validation, Technical Services or Quality Assurance functions.
/li liExtensive experience in validation and qualification of equipment and systems within cGMP-regulated environments.
/li liStrong knowledge of EU and FDA regulatory requirements, with direct exposure to regulatory inspections (e.g., FDA/DEA).
/li liProven background in managing validated/qualified systems.
/li liStrong capability to define and execute strategies to effectively manage multiple projects simultaneously.
/li liSolid technical problem-solving skills, with the ability to assess risks and implement balanced, compliant solutions.
/li liHigh level of initiative, accountability, and decision-making ability, with capacity to work effectively with minimal supervision.
/li liExcellent teamwork and interpersonal skills, with the ability to build constructive relationships across all organizational levels.
/li /ul h3We would prefer for you to have /h3 ul liExperience in Cleaning Validation is highly preferred.
/li /ul h3Technical Competences /h3 pValidation, Qualification Compliance Responsibilities /p ul liOversee the preparation and issuance of Validation Project Plans (VPP) and Validation Final Reports (VFR), actively contributing to their development.
/li liSupervise the preparation of Technology Transfer documentation, ensuring completeness and regulatory compliance.
/li liLead validation and qualification activities by defining objectives and timelines, reviewing data, and identifying necessary corrective actions.
/li liCollaborate to the site equipment lifecycle management, ensuring proper execution of qualification, maintenance, and calibration plans.
/li liPerform QA review and approval of validation documentation throughout the equipment/instrument lifecycle (URS, DQ, FAT, SAT, IQ, OQ, PQ, PV).
/li liSupport investigations of qualification deviations, identifying appropriate corrective actions and assessing regulatory and operational impact.
/li liManage environmental validation activities and cleaning validation programs for manufacturing facilities.
/li liEnsure pharmaceutical transport compliance with GDP requirements through the issuance of shipping validation protocols and reports.




/li liSupport new site projects by ensuring qualification and validation strategies meet regulatory and corporate standards.
/li liContribute to the development of ongoing process verification plans and related documentation.
/li /ul pData Integrity, Risk Management Process Validation /p ul liEnsure Data Integrity compliance through review of Computerized System Validation (CSV) documentation and support periodic review plans.
/li liSupport process risk assessments to identify Critical Process Parameters (CPPs), Critical Quality Attributes (CQAs), and define appropriate validation strategies.
/li liCoordinate cross-functional teams in performing risk assessments for new projects and regulatory submissions (major and minor changes), ensuring site compliance with regulatory authorities.
/li liCollaborate with Production to ensure compliance with GMP and production plans, supporting process validation and cleaning validation activities.
/li /ul pQuality System Continuous Improvement /p ul liSupport Site Quality in the investigation of complaints and quality events; define and implement CAPA plans resulting from audits and inspections.
/li liIssue and maintain procedures within the area of responsibility.
/li liParticipate in self-inspections, regulatory authority inspections, and customer audits.
/li liMaintain and control the Validation Change Control Program for validated/qualified systems and the Validation Management System (VMS).
/li liReview and approve the Validation Master Plan (VMP).
/li liAct as SME for process validation topics, including process changes, cleaning validation, hold times, and analytical instrumentation qualification.
/li liDeliver training on Validation, Qualification, and Change Management processes.
/li liDrive continuous improvement initiatives aimed at streamlining validation processes and reducing non-value-added activities.
/li liProvide leadership and guidance for validation-related CAPA activities.
/li liParticipate in Quality Risk Management activities, contributing to FMEAs and Risk Control Plans as Validation SME.
/li /ul h3Location /h3 pParma /p h3Budgeted Salary Range /h3 pThe budgeted salary range approved for this role is between €****** and €****** .
This range reflects the typical compensation expected for candidates with the experience and expertise required for the position.
/p pFinal offer may vary based on the selected candidate's skills, experience, qualifications, overall profile, and internal equity considerations.
/p pThis role is eligible to participate in an annual premio scheme, subject to company and individual performance.
/p pIn addition, we offer a comprehensive benefits package including pension, private medical insurance, wellbeing programme, flexible benefits programme.
/p pbWhat we offer /b /p pNo matter where your path starts at Chiesi, it leads to inspiring possibilities.
Your future is our focus, and we are committed to nurturing your development in our dynamic, friendly environment with access to resources and training every step of the way.
/p pWe provide top-class benefits, including comprehensive healthcare programs, work-life balance initiatives, and robust relocation support.
Our salary package is competitive, comprising a basic salary, performance bonuses, and benefits benchmarked against the external market.
Additionally, we offer flexible working arrangements, remote work options, and tax assistance services for foreign colleagues, all designed to help you thrive.
/p pChiesi is an equal opportunity employer committed to hiring a diverse workforce at all levels of our business.
All qualified applicants receive consideration for employment based on attitude and merit, without regard to race, national origin, age, sex, religion, disability, sexual orientation, marital status, military status, gender identity or expression, or any other basis protected by applicable laws.
This policy applies to all aspects of employment, including hiring, transfer, promotion, compensation, eligibility for benefits, and termination.
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📌 Validation & Equipment Compliance Manager (Parma)
🏢 Chiesi Farmaceutici
📍 Parma