Project Manager Qualification & Validation Specialist

Project Manager Qualification & Validation Specialist

Location: On-site Barcelona
Type: Full-time

What do we expect from you as a Project Manager Qualification and Validation Specialist As a Project Manager Qualification & Validation specialistyou work on multiple projects in Barcelona within several organizations within the pharmaceutical or Medical device related industry. You are responsible for effective and efficient validation and qualification of laboratory equipment cleanrooms utilities HVAC systems GMP production equipment medical devices and processes.

Whats in it for you

Make a real impact: Contribute to shaping the future of the Life Sciences industry by supporting innovative projects and clients across pharma biotech and medical devices

Grow within a community of experts: Benefit from knowledge-sharing mentoring and exposure to diverse challenging assignments that broaden your expertise.

Build a meaningful career: As an ambitious and pioneering company we want to offer you the best possible environment to thrive within the life sciences.

A fair competitive package: We offer tailored transparent compensation aligned with your expertise preferences and local market regulations because your contribution deserves to be valued.

What youll be doing

Main Responsibilities

• Collaborate closely with Division Heads to support project planning coordination and follow-up ensuring alignment between technical validation activities and overall project timelines and objectives.

• Provide quality and validation oversight to ensure that validation qualification and other life cycle activities are consistent with company validation policies procedures and federal regulations;

• Support process validations (IQ/OQ/PQ) and cleaning validation;

• Identify critical areas for improvement and prioritize and execute the initiatives.

• Perform or support nonconformance / CAPA root cause investigations defining action plans and driving these to completion;

• Proceed according to the companys quality policy in all business activities;

• Provide advice to improve the quality policies and validation procedures

• Provide coaching training and guidance on validations; Implement controls to ensure data integrity and traceability of Quality records;

• Act as a subject matter expert during internal and external audits (e.g. FDA).

What you bring

• You have an academic background related to areas such as pharmacy chemistry biology engineering and related fields.

• You have at least 8 years of experience in qualifications/validations within validation departments in the pharmaceutical sector medical devices biotechnology...

• You have experience in qualification/validation documentation management: VP URS IQ OQ PQ.

• You have a good understanding of Annex 1 guidelines for validation purpose.

• You have experience in complete processes of validations: protocols and validation reports.

• You have an advanced level of English: you should be able to write technical documentation in English. Spoken English will also be an advantage as you will be joining a multinational company.

• You have user-level computer skills: word processing spreadsheet and database.

• You have a strong ability to self-manage and love working in a team. Rigour and proactivity are highly desirable.

• You have excellent communication skills.

• You are an autonomous person with the ability to adapt.

• You are able to adapt to high quality standards data integrity GMP

Who you are

Our culture is driven by values If this sounds like you youll fit right in:

• Youre resilient and tackle challenges with a positive mindset

• Youre curious and always up for learning something new

• You have a no non-sense approach honest clear respectful

• Youre innovative and bring ideas not just opinions

• And above all youre serious about your work but not too serious about yourself

About us

We support life sciences companies from idea to patient offering tailored solutions in development clinical regulatory compliance production and distribution. With 500 experts across 8 countries we help drive innovation in ATMP biotech medical devices diagnostics digital health and pharma.

We believe in JPEG:
Joy. Partnership. Going the Extra Mile. Getting Things Done.

You wont just be taking a job youll be joining a community where people grow laugh build and contribute to something bigger.

Interested Lets talk.
Send us your CV and motivation letter. You could be the next one to join the QbD family.