Technicien Chimiste Purification - Lessines, België - ARIAD

ARIAD

Geverifieerd bedrijf

Lessines, België

1 week geleden

Geplaatst door:

Sophie Dubois

beBee Recruiter

Beschrijving

Small Molecules

Biologics
Plasma
Cell and Gene

As part of the GMS team, you'll have the opportunity to pursue unique experiences and build new skills, and you'll know that the work you do every day makes an impact — on our patients, our people, our planet, and on yourself.

Job ID R0107291
Date posted 12/14/2023
Location Social Circle, Georgia
About the role:
Join Takeda as a Senior Validation Engineer where you will support site projects, technical transfers, and ongoing validation maintenance.

You will focus on the design, authorship, and execution of commissioning, qualification and/or validation studies and report to the Engineering Validation Manager at our location in Social Circle, GA.

How you will contribute:

Facilities, Utilities, and Equipment (FUE) qualification
Units operations automation qualification with Honeywell, Delta V, and PCLbased systems
Computerized systems validation
Cleaning validation
Sterilization validation
Materials validation
Process validation

What you bring to Takeda:

Job responsibility and Description:

Independently designs, authors, executes and summarizes commissioning, qualification and/or validation studies. Partner with SMEs to ensure efficient execution of testing strategies.
Collaboratively conduct risk and impact assessments.
Support development and review of standard operating procedures (SOP) and validation assessments.
Communicate with customers on technical issues, project timelines and validation support.
Participate on teams to determine the rootcause and corrective actions for problems associated with investigations.
Calculation and interpretation of data for commissioning, qualification and/or validation studies.
Participate in audits and regulatory agency inspections as a representative of the Engineering Validation team.
Support development of best demonstrated validation practices within the validation department, based on current industry practices and guidelines.
Support operations and communications with Program Managers.
Exercise judgment within defined policies in selecting methods, techniques, and evaluation criteria for obtaining results. May determine methods and procedures on new assignments.
Demonstrate continuous improvement concerning increasing job knowledge and proficiency related to validation in the biopharmaceutical industry, and technical understanding/problemsolving capability.
Lead several small projects with complex features.
Serve on Tier 1 process teams.

Minimum Requirements/Qualifications:

Bachelors degree in Engineering discipline required. Minimum 7 years validation experience for nonmanager role; 5+ years experience for Supervisor.
7 years of relevant experience in a GMP regulated environment.
At least 4 years of commissioning, qualification and validation (CQV).
Validation and/or system experience in the following applicable areas:
Sterilization and aseptic processing validation.
Cleaning validation

of manufacturing equipment.

Process and utility systems validation, temperature mapping, manufacturing equipment commissioning and qualification.
Protein purification from mammalian plasma and/or blood.
Technical experience with automation platforms, such as DeltaV, Honeywell, Rockwell PLC, Siemens XFP.
Lead validation projects, coordinate contractors, and achieve results.
Direct experience with manufacturing operations and biotechnology processes

Key Skills, Abilities, and Competencies:

Must work in a team environment, working with individuals at all levels in an organization and departmental areas.
Ability to be flexible to address both shifting priorities and changes in approach in work environments.
Knowledge of Industry guidelines (ISPE, PDA), US and international regulations (FDA, ICH, ISO, EU) for GMP regulated environments.
Proficient problem solver.
Proficiency with Word, Excel, and PowerPoint. Microsoft Project and Visio a plus.

Complexity and Problem Solving

Excellent analytical skills with systematic approaches to problem solving. Can break down complex problems and tasks into manageable activities.
Knowledge of basic principles in multiple engineering disciplines.

Internal and External Contacts

Interaction with manufacturing, schedulers, maintenance and quality staff to secure equipment allocation to support execution activities.
Interaction with project managers for schedule adherence.

Other Job Requirements

May work weekends, evenings, offhours, extended periods of time.
Occasionally, may lift up to 50 pounds.
Need to gown and operate in an environment requiring gowning.
Up to 10% travel expected.

What Takeda can offer you:

Comprehensive Healthcare: Medical, Dental, and Vision
Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan
Health & Wellness programs including onsite flu shots and health screenings
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