A career with MilliporeSigma is an ongoing journey of discovery: our 52,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others. MilliporeSigma is a business of Merck KGaA, Darmstadt, Germany.
The Carlsbad Gene Therapy and Viral Vector Manufacturing contract manufacturing site produces drug substance and drug products for gene therapy and oncology applications.
The Validation Engineer is an Engineering Department core team member in the Validation Group tasked with defining, authoring, executing and closing Validation qualification testing activities for manufacturing process equipment and instruments, lab equipment, computer and controls systems, as well as initiating controlled documentation (e.g. SOPs, Project Plans, URS), and providing client support for Validation projects as part of a larger team.
This role will define, plan, and manage validation projects while meeting applicable regulatory requirements. You will have responsibility to author and execute or witness execution of Validation Protocols, Factory Acceptance Tests (FATs), Site Acceptance Tests (SATs), Vendor Start-up and Testing, Commissioning and cycle development study prep, planning and development of final reports. Additionally, you will perform deviation investigation, troubleshooting and resolution of problems and issues encountered during field execution activities and generate deviation reports as required.
The Validation Engineer will also manage project documentations such as protocols, reports, calibration certificates, and process trends. You must be detail oriented and have the ability to provide self-direction, with superior skills in planning, organizing, and communicating project tasks across a multidisciplinary team. Must be capable of working independently as well as in a team and communicating project objectives, scheduled timelines, progress updates, and project risk factors to the Engineering Department Manager.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties, the employee is: Constantly required to sit and reach to use computers and other office/lab equipment. Occasionally standing for extended periods of time, up to four (4) to five (5) hours/time. You may be required to lift up to fifty (50) pounds, constantly required to view objects at close and distant ranges, and frequently required to communicate with others.
Employee frequently works in a professional office environment and lab with computer equipment, machinery, tools, and moderate amounts of noise and activity. Employee may occasionally be exposed to fumes, airborne particles, chemicals, vibration and biohazardous materials. The work environment is fast-paced and demanding. This position has the utmost responsibility for compliance with the rules and regulations regarding a safe and healthy work environment. Off-shift, weekend, and overtime duties may be required as assigned by the manager of the employee.
Who You Are:
- Bachelor’s degree is required
- 4+ years’ experience in Pharmaceutical/ Biotech in an Engineering, Commissioning or Validation role
- Comprehensive working knowledge/application of GMP and Part 11 compliance as they relate to qualification of systems in support of validation of processes
- Experience with production and engineering support principles and concepts, including a professional understanding of best practices, techniques and standards
What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!
Curious? Apply and find more information at https://jobs.vibrantm.com
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.