Validation Specialist Associate - Mirandola Area Italy

ProductLife Group; Mirandola; Ibrido; EUR 38.000 - 52.000; Tempo pieno

Descrizione del lavoro

ProductLife Group is seeking a Validation Specialist Associate to join PLG Center of Expertise Engineering around Mirandola, Italy, with a hybrid work policy. You will own qualification and validation activities for facilities, utilities and equipment, and contribute to GMP-compliant documentation.

You will draft protocols and reports, coordinate validation tasks, support CAPAs and risk assessments, and collaborate with QA, Production and Engineering to ensure validated states and ongoing

Competenze

• Bachelor's/ Master's degree in Engineering, Life Sciences, Chemistry, Pharmacy, or a related discipline.
• 1-2 years relevant professional experience
• Experiences in qualification and commissioning
• Writing Skills (Sentence Structure and Construction, Clarity and Effectiveness,)
• Experience in drafting qualification protocols, reports, SOPs, and other GMP documentation.
• Good understanding of GMP requirements and validation principles.

Mansioni

• Plan, execution, and documentation of qualification and validation activities (IQ/OQ/PQ) for facilities, utilities and equipment.
• Preparation and review of validation protocols, reports and related documentation
• Coordination of qualification and validation activities, ensuring timely execution and documentation review
• Ensure compliance with GMP requirements and internal quality standards
• Support change controls, deviations, CAPAs, and risk assessments related to validation
• Collaborate with clients cross-functional teams (QA, Production, Engineering, QC) to support validation projects
• Maintain validation documentation and ensure the validated state of equipment and processes
• Draft Validation Master Plan
• Risk analysis and drafting SOPs

Conoscenze

Engineering degree

Validation

GMP documentation

IQ/OQ/PQ

Cross-functional collaboration

Formazione

Bachelor's or Master's in Engineering/Life Sciences/Pharmacy

Descrizione del lavoro

About Us

ProductLife Group (PLG) is a dedicated life sciences and pharmaceutical outsourcing and consulting company providing expertise and services in areas such as: Product Development, Market & Patient Access, Regulatory Affairs and Safety & Vigilance as well as Engineering and Digital Transformation.The group has its HQ in Paris and affiliates around the globe with teams in all key regions: North America, Europe and APAC.

About Us

ProductLife Group (PLG) is a dedicated life sciences and pharmaceutical outsourcing and consulting company providing expertise and services in areas such as: Product Development, Market & Patient Access, Regulatory Affairs and Safety & Vigilance as well as Engineering and Digital Transformation.The group has its HQ in Paris and affiliates around the globe with teams in all key regions: North America, Europe and APAC.

We are now seeking a Validation Specialist Associate to enhance and join PLG Center of Expertise Engineering (previousl y C&P Engineering). Our Center of Expertise, is a multidisciplinary engineering and consulting firm specializing in providing tailored solutions for the pharmaceutical, medical, nutraceutical, and cosmetics industries in areas such as Engineering, Construction, Qualification & Validation as well as Energy & Waste Management.

The job location is around Mirandola in Italy with a hybrid working policy.

About The Job

You will have ownership of the following activities supporting our clients' Qualification & Validation Opeeations:

• Plan, execution, and documentation of qualification and validation activities (IQ/OQ/PQ) for facilities, utilities and equipment
• Preparation and review of validation protocols, reports and related documentation
• Coordinationn of qualification and validation activities, ensuring timely execution and documentation review
• Ensure compliance with GMP requirements and internal quality standards
• Support change controls, deviations, CAPAs, and risk assessments related to validation
• Collaborate with clients cross-functional teams (QA, Production, Engineering, QC) to support validation projects
• Maintain validation documentation and ensure the validated state of equipment and processes
• drafting Validation Master Plan
• risk analysisdrafting SOPs

Required Skills And Experience

• Bachelor's/ Master's degree in Engineering, Life Sciences, Chemistry, Pharmacy, or a related discipline.
• 1-2 years relevant professional experience
• Exp riences in qualification and commissioning
• Writing Skills (Sentence Structure and Construction, Clarity and Effectiveness,)
• Experience in drafting qualification protocols, reports, SOPs, and other GMP documentation.
• Good understanding of GMP requirements and validation principles.

Additional Skills

• Attention to detail
• Team working
• Problem solving
• Good Interpersonal skills
• Flexibility and willingness to travel to client sites as required.