MP Solutions

Self-funded software solutions provider globally

Validation Engineer - Pharma and Medical sector

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours

Full-timeBudapest, HungaryNo salary listed

About the Job

Requirements

A minimum of 6 years of experience in validation, quality assurance, or a related role in industries such as MedTech, pharmaceuticals, biotechnology, medical devices, or manufacturing.
A minimum Bachelor's degree in Engineering, for example mechanical engineering, production engineering, or a similar field.
Experience designing and executing tests and writing and reviewing scientifically and technically complex documentation.
Familiarity with production, including Good Manufacturing Practice (GMP) and quality assurance (QA).
Proficiency in validation tools and software.
Knowledge of regulatory standards, including FDA and GMP.
Familiarity with statistical analysis and risk assessment programs.
Analytical and problem-solving abilities.
Strong communication and interpersonal skills, and the ability to plan and ensure progress in a complex interdisciplinary environment.
Fluency in spoken and written English.
Willingness to travel up to 30–60 days per year, with flexibility according to client needs.

Responsibilities

Develop validation protocols for systems, equipment, and/or processes.
Execute installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) protocols.
Execute risk assessments and gap analyses on systems or processes, including process Failure Mode, Effects, and Criticality Analysis (pFMECA) and hazard assessment.
Ensure documentation complies with industry regulations, including FDA, ISO, and GMP.
Identify and report validation deviations and propose corrective actions in collaboration with quality assurance functions.
Ensure validation activities align with applicable regulatory requirements, including FDA 21 CFR Part 11, ISO 9001, and ISO 13485.
Collaborate with Quality Assurance and Regulatory Affairs teams to ensure and maintain compliance.
Work with research and development and manufacturing teams to integrate validation processes into project development workflows.
Analyze validation processes on an ongoing basis to identify opportunities for improvement.

Desired Qualifications

Familiarity with equipment commissioning, including user requirements specifications (URS), risk management, factory acceptance testing (FAT), site acceptance testing (SAT), validation, and operating and maintaining equipment and moulds.
Project management.

Validation Engineer - Pharma and Medical sector

MP Solutions Ltd. · Budapest, Hungary (Hybrid) · Full-time · Posted 2025-01-17

Workplace: hybrid

Department: MPS PRS

Description

Our client are developing new products and improving/ optimizing existing products and production lines in close dialogue with customers and partners. The company also offers consultants for production support, optimization, validation; project management and quality assurance just to name a few. The customers are often the leading international companies in their specific field

Position:

As Validation Engineer you play a crucial role in ensuring that products, systems, and processes meet specified requirements and standards before released to the market or implemented. The Validation Engineer ensures that products, equipment, systems, and processes comply with regulatory requirements, industry standards, and company-specific guidelines. This role involves developing and executing validation plans, conducting tests, and documenting results to confirm compliance and functionality.

Key Responsibilities:

o URS, DQ, FAT, SAT, IQ, OQ, PQ

o Develop validation protocols for systems, equipment and/or processes

o Execute qualification protocols for installation (IQ), operational performance (OQ) and performance load (PQ)

o Execute risk assessments and gap analyses on systems or processes, pFMECA, Hazard

o Ensure documentation complies with industry regulations (e.g., FDA, ISO, GMP)

o Identify and report any validation deviations and propose corrective actions in collaboration with QA functions

You ensure all validation activities align with applicable regulatory requirements (e.g., FDA 21 CFR Part 11, ISO 9001, ISO 13485). You collaborate with Quality Assurance an Regulatory Affairs teams to ensure and maintain compliance. You work closely with R&D and manufacturing to integrate validation processes into project development workflows as well as you ongoing analyze validation processes to identify opportunities for improvement.

Requirements

You have minimum +6 years of experience in in validation, quality assurance, or a related role in industries such as MedTech, pharmaceuticals, biotechnology, medical devices or manufacturing.
You have a min Bachelor´s degree in Engineering (e.g. mechanical engineering, productions engineering or similar).
You have gained experience with designing and executing tests, with writing and reviewing scientific with a high technical complexity, and you are familiar with both production (including GMP and QA).
Proficiency in validation tools and software
Knowledge of regulatory standards (FDA, GMP, ISO, etc.)
Familiarity with statistical analysis and risk assessment programs
Maybe you are familiar with equipment commissioning (URS, risk management, FAT/SAT, validation and operating/maintaining of equipment and moulds)
Project management
You have analytical and problem-solving abilities.
You are self-driven, action- and detail-oriented and you can navigate professionally in and dynamic environment. You have a positive attitude.
Due to your strong communication and interpersonal skills and your approach to planning, you ensure progress in a complex and interdisciplinary environment.
You are fluent in English (both in verbal and in writing).
you are willing to travel up to 30-60 days a year (with flexibility according to client needs) and you will have the chance to meet new cultures, new companies, crossfunctional teams – to increase your competences

Benefits

You get great opportunity to make an impression on your job function and your daily work. The policy of the company is always to meet customers′ requirements and expectations. It is a company with flat structure, short decision-making paths. There is an ambitious atmosphere and pioneering spirit in the workplace. Focus on developing new products and improving/ optimizing existing products and production lines in close dialogue with customers and partners. The team (today about 40 people) consists of dedicated engineers, technicians and sales representatives, all of whom are highly qualified within their specific professions.

Apply

Apply at MP Solutions Ltd.

About the Company

MP Solutions

Self-funded software solutions provider globally

MP Solutions is a small, self-funded team focused on delivering practical solutions to a global audience. They emphasize hands-on involvement by owners, who work closely with the team and live in the same environment to stay aligned with customers’ needs. The company’s offerings center on providing suited solutions to millions of happy users around the world. Their approach is to work directly with clients to understand problems and deliver concrete results rather than abstract plans. MP Solutions differentiates itself through owner-led, hands-on management and a tightly knit, self-funded structure that keeps the team closely aligned with customer success. The goal is to keep delivering high-quality solutions that meet real user needs and expand their global impact.

Company size: 11-50
Company stage: Not listed
Total funding: Not listed
Headquarters: Hanoi, Vietnam
Founded: 2018

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