Validation Officer

Productlife Group; Lazio; In loco; EUR 34.000 - 39.000; Tempo pieno

Descrizione del lavoro

Productlife Group is seeking a Validation Specialist in Italy (Lazio) to perform calibration and qualification activities for facilities, utilities and equipment, and to prepare validation protocols and reports.

The role requires 3-4 years of experience, a Bachelor’s degree in a relevant field, and fluency in English and Italian. Travel to client sites may be needed along with strong GMP knowledge.

Competenze

• Bachelor's degree in engineering or related life sciences fields.
• 3-4 years of validation experience.
• Professional English and Italian language skills.
• Knowledge of GMP regulations.
• Experience drafting qualification protocols, reports, and SOPs.
• Experience in qualification and commissioning.

Mansioni

• Execute and document calibration and qualification activities (IQ/OQ/PQ) for facilities, utilities and equipment.
• Prepare validation protocols, reports and related documentation.
• Maintain validation documentation and ensure the validated state of equipment and processes.
• Collaborate with QA, Production, Engineering, QC on validation projects.
• Draft SOPs and validation master plan.

Conoscenze

English

Italian

Attention to detail

Team working

Problem solving

Interpersonal skills

Willingness to travel

Formazione

Bachelor's degree in Engineering, Life Sciences, Chemistry, Pharmacy, or related

Strumenti

Office 365

Descrizione del lavoro

Specific activities and responsibilities:

• Execution, and documentation of calibration and qualification activities (IQ/OQ/PQ) for facilities, utilities and equipment
• Preparation of validation protocols, reports and related documentation.
• Knowledge of GMP regulations.
• 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 SOPs.
• Drafting validation master plan.

Required experience: 3-4 years

Required Education: Bachelor's degree in Engineering, Life Sciences, Chemistry, Pharmacy, or a related discipline.

Required Languages: English + Italian (fully professional/native level).

Required technical skills:

• Office 365 (Word, Excel, PowerPoint, Outlook).
• Experience 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 experience and/or skills:

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

Annual Compensation Range: EUR 34,000 - 39,000.

The compensation range indicated in this job posting represents an estimated range for the position. The final remuneration will be determined based on the selected candidate’s experience, skills, qualifications, and internal compensation policies, in accordance with applicable EU and local pay transparency and pay equity requirements.