Are you great as a validation engineer? If you are interested to work for one of the leading pharmaceutical companies in the world then have a look at the job description below.
Main Responsibilities
- In this role, you will be responsible for Validation activities for (new) biopharmaceutical processes in the Late-Stage Development department.
- The Lead Validation Engineer directly reports to the Validation Manager and is the end-to-end responsible for that validation studies are carried out to conform to global and local company policies and procedures as well as legal requirements and requirements set by regulatory authorities.
- Under limited supervision: performs technical work, provides validation and project management services, and/or develops concepts, assessments, and details independently or with little supervision. Carries out all the E2E validation tasks, assists the project manager in delivering projects, and supports diverse project-related tasks. As needed the Lead Validation Engineer will be able to identify the need for, the design and the planning for executing all the E2E validation demands of a given project/task and confirms the interpretation of the final validation outcome. The Lead Validation Engineer highly understands the drug development process and the required process and validation expectations at each stage.
- Define strategy, plan, coordinate and execute the core business phases of Lifecycle Process validation activities based on specific assigned roles and responsibilities
- Ensure the validation activities are properly planned and executed as per the Lifecycle Process validation process
- Ensures the validation activities are reported back in the applicable site Supporting Validation Plans and Validation Master Plans
- Authoring, reviewing and approving validation plans, protocols, reports
- Perform risk/criticality assessments, technical and GMP-related documentation
- Bridging with multi-functional teams handling and ensuring facilities, equipment, and process readiness for GMP production
- Proven experience with process validation-related activities such as (but not limited to): cleaning validation of product contact equipment, process performance qualification (PPQ), continued process validation (CPV), media fill (APS), sterility assurance relevant supporting validation activities such as (but not limited to) smoke studies in operations, CCIT, sterile hold time, vessel integrity and filter validation.
Your Profile:
- MSc degree (or BSc with an increased level of experience: 7-9 years) in technical or life sciences
- A minimum of 6 years of working experience within a pharma company in a validation or equivalent position
- Experience working in different project teams at the same time
- Experience in project management
- Fluency in English
- Fluency in German is a plus
- Excellent interpersonal skills
- Proficiency in Word, Excel, PowerPoint, Visio & MS Project
- Analytical thinking, teamwork, and problem-solving ability
- Able to manage multiple priorities simultaneously
- Ability to work with limited supervision
We are looking forward to your applications. Good luck
Are you great as a validation engineer? If you are interested to work for one of the leading pharmaceutical companies in the world then have a look at the job description below.
Main Responsibilities
- In this role, you will be responsible for Validation activities for (new) biopharmaceutical processes in the Late-Stage Development department.
- The Lead Validation Engineer directly reports to the Validation Manager and is the end-to-end responsible for that validation studies are carried out to conform to global and local company policies and procedures as well as legal requirements and requirements set by regulatory authorities.
- Under limited supervision: performs technical work, provides validation and project management services, and/or develops concepts, assessments, and details independently or with little supervision. Carries out all the E2E validation tasks, assists the project manager in delivering projects, and supports diverse project-related tasks. As needed the Lead Validation Engineer will be able to identify the need for, the design and the planning for executing all the E2E validation demands of a given project/task and confirms the interpretation of the final validation outcome. The Lead Validation Engineer highly understands the drug development process and the required process and validation expectations at each stage.
- Define strategy, plan, coordinate and execute the core business phases of Lifecycle Process validation activities based on specific assigned roles and responsibilities
- Ensure the validation activities are properly planned and executed as per the Lifecycle Process validation process
- Ensures the validation activities are reported back in the applicable site Supporting Validation Plans and Validation Master Plans
- Authoring, reviewing and approving validation plans, protocols, reports
- Perform risk/criticality assessments, technical and GMP-related documentation
- Bridging with multi-functional teams handling and ensuring facilities, equipment, and process readiness for GMP production
- Proven experience with process validation-related activities such as (but not limited to): cleaning validation of product contact equipment, process performance qualification (PPQ), continued process validation (CPV), media fill (APS), sterility assurance relevant supporting validation activities such as (but not limited to) smoke studies in operations, CCIT, sterile hold time, vessel integrity and filter validation.
Your Profile:
- MSc degree (or BSc with an increased level of experience: 7-9 years) in technical or life sciences
- A minimum of 6 years of working experience within a pharma company in a validation or equivalent position
- Experience working in different project teams at the same time
- Experience in project management
- Fluency in English
- Fluency in German is a plus
- Excellent interpersonal skills
- Proficiency in Word, Excel, PowerPoint, Visio & MS Project
- Analytical thinking, teamwork, and problem-solving ability
- Able to manage multiple priorities simultaneously
- Ability to work with limited supervision
We are looking forward to your applications. Good luck
