Overview
Lincotek, headquartered in Rubbiano, Parma, Italy, is a global contract manufacturer for services in markets including Industrial Gas Turbines, Aerospace and Medical Device applications, as well as a leading manufacturer of industrial coating equipment and one of the most respected producers in the Additive Manufacturing field. The Group has more than 1,800 employees located in 18 production facilities across Europe, North America and Asia. For our site in Cadriano (BO) we\'re searching for a qualified and resourceful Process Validation Specialist.
About the Job
The Process Validation Specialist will be responsible for planning, reviewing, executing, and documenting process validation activities, ensuring that manufacturing processes comply with applicable standards, ISO 13485, company policies, and regulatory requirements.
The role will work closely with Production and Engineering teams to ensure proper monitoring, qualification, and validation of manufacturing processes and equipment used in a machining production environment.
Responsibilities include executing primary validation activities for equipment and systems supporting the manufacturing process and coordinating validation activities with vendors and customers when required.
The Process Validation Specialist will apply validation and continuous improvement techniques, including risk management tools (e.g., FMEA), Design of Experiments (DOE), and basic process monitoring and statistical techniques, to support robust and compliant manufacturing processes.
Main Responsibilities
* Plan, develop, conduct, and document process validation activities (IQ/OQ/PQ) for production equipment and processes.
* Prepare and maintain validation protocols, reports, and technical documentation.
* Collaborate with Production and Engineering teams to identify process risks and implement mitigation actions.
* Analyze process data and test results to ensure compliance with regulatory, internal, and customer requirements.
* Participate in Root Cause investigations and CAPAs related to process deviations or non-conformances.
* Support change control activities and new product/process development, assessing validation requirements and ensuring modifications are properly evaluated and validated when required.
* Coordinate validation activities with external vendors and customers, as needed.
* Review customer specifications and technical requirements to support validation planning and qualification activities.
* Ensure validation projects are completed on time and within budget.
* Maintain and revise Quality procedures, plans, and work instructions related to validation activities.
* Support internal and external audits, presenting validation documentation and evidence.
* Contribute to continuous improvement initiatives for manufacturing processes.
* Adhere to the Company\'s Quality and Safety Management System and in accordance with its procedures and requirements.
* Contribute to continuous improvement of manufacturing processes, identifying opportunities for optimization.
* Perform all duties in accordance with all company policies including adherence to good safety practices. Training of personnel.
* Performs other duties as assigned.
Qualifications and Experience
* Bachelor’s degree in Engineering, Biomedical Engineering, Mechanical Engineering, Materials Science, or related technical field.
* 2–5 years of experience in Process Validation, Quality Engineering, or Manufacturing Engineering, preferably in the medical device industry.
* Knowledge of ISO 13485, Medical Device Regulations, and process validation principles.
* Experience with IQ/OQ/PQ, PPQ, validation protocols, and technical documentation.
* Familiarity with risk management tools (e.g., FMEA) and basic statistical analysis methods.
* Experience in machining, precision manufacturing, coatings, or medical device production is considered a strong advantage.
Skills
* Strong analytical, problem-solving, and organizational skills with the ability to manage multiple priorities.
* Ability to work effectively in cross-functional teams and collaborate with Engineering and Production departments.
* Good written and verbal communication skills in English.
* Ability to read, analyze, and interpret technical drawings, blueprints, specifications, and procedures, and to prepare clear technical documentation.
* Understanding and practical use of precision measuring devices and measurement techniques used to evaluate component characteristics.
* Ability to work with initiative and sound judgment, ensuring high standards of quality and productivity.
* Good knowledge of Microsoft Office tools (Excel, Word, PowerPoint); familiarity with Microsoft Project and ERP systems, preferably SAP, is considered a plus.
* Basic project management knowledge, including planning and monitoring activities using Gantt charts or similar planning tools, is considered a plus.
* Self-motivated with strong organizational and multitasking abilities.
* Strong attention to detail with the ability to identify discrepancies and ensure data accuracy.
Work Environment and Additional Information
This job operates in both an office environment and a manufacturing environment. The role routinely uses standard office equipment, such as computers, phones, photocopiers, filing cabinets, and fax machines. The individual will be required to adhere to safety policies and procedures on the manufacturing floor.
Physical Demands: Limited physical demand may be needed. Physical demands will involve standing, walking, and occasionally moving or lifting material.
Position Type/Hours: This is a full-time position, with business core hours of Monday through Friday 8am to 5.30pm, with additional hours as business needs necessitate.
Travel: Occasional overseas and domestic travel may be required to support the rapid growth of the company.
Equal Employment Opportunity: Lincotek provides equal employment opportunity to all individuals regardless of race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by state, federal, or local law.
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