A career with MilliporeSigma is an ongoing journey of discovery: our 57,000 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.Define, plan, and manage validation projects while meeting applicable regulatory requirements;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;Perform deviation investigation, troubleshooting, and resolution of problems and issues encountered during field execution activities and generate deviation reports as required;Apply comprehensive working knowledge/application of GMPs, GCPs, GLPs, GAMP, and Part 11 compliance as they relate to qualification of systems in support of validation of processes;Promote and integrate cGMP regulatory compliance and quality by design (QbD) approach into assigned projects;Prepare written Standard Operating Procedures (SOPs), Impact Assessments, Risk Assessment, FMEA, Specifications (URS/FRS/DDS), FATS/SATs, Validation Protocols, Protocol Execution and Validation Final Reports;Generate and/or review equipment specifications, owner project requirements, specifications, checklists, and test data as required;Document, monitor, and report on project deliverables; andManage project documentations such as protocols, reports, calibration certificates, and process trends
Job Title: Validation Engineers
Job Location: SAFC Carlsbad, Inc., 6211 El Camino Real, Carlsbad, CA 92009
The Validation Engineer will be defining, authoring, executing, and closing validation qualification testing activities for manufacturing process equipment and instruments, lab equipment, computer and controls systems, and activities for multiple clients and products, as well as initiating controlled documentation (e.g., SOPs, Project Plans, and URS) and providing client support for validation projects as part of a larger team.
In particular, the Validation Engineer will perform the following job duties:
Employer requires a Master's degree in Mechanical Engineering or a closely related field, and must have at least four years of work experience with equipment, utility, and facility qualification and requalification in or working with the pharmaceutical or medical device industry. In addition, the employer requires the following:Demonstrated knowledge of quality principles including ISO, Quality Management Systems, and Quality by Design gained through at least four (4) years of work experience;Demonstrated knowledge of risk assessment quality tools, e.g., FMEA, gained through at least four (4) years of work experience;Demonstrated knowledge of Computer System Validation through at least four (4) years of work experience; andDemonstrated knowledge of Life-Cycle Documentation in GMP-regulated pharmaceutical or medical device industries gained through at least four (4) years of work experience.
All years of experience may be gained concurrently.
Applicants can mail via USPS resumes to SAFC Carlsbad, Inc., 400 Summit Drive, Burlington, Massachusetts 01803 (Attn: req# 215449)This position is eligible for SAFC Carlsbad's Employee Referral Program.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.
Job Requisition ID: 215449
Career Level: D - Professional (4-9 years)
Working time model: full-time
This job has expired.