Who we are:
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 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 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 and activities for multiple clients and products; 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.
Validation Engineer possesses comprehensive knowledge and understanding of requirements for GLP and cGMP clinical and commercial environments.
ESSENTIAL JOB FUNCTIONS
Facility, Equipment and Systems Support
- Defines, plans and manages 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.
- Performs deviation investigation, troubleshooting and resolution of problems and issues encountered during field execution activities and generate deviation reports as required.
- A 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.
- Write documents following established standards and templates, including but not limited to the following:
- Standard Operating Procedures (SOPs)
- Impact Assessments
- Specifications (URS/FRS/DDS)
- Validation Protocols
- Protocol Execution
- Validation Final Reports
Project Management and Team Leadership Support
- Takes a proactive role in supporting site validation projects and in providing client support.
- Build a high level of trust with internal and external clients, developed through consistently upholding MilliporeSigma Values and demonstrating Honesty, Integrity, Pride, Accountability, Teamwork, and Commitment.
- Assist the project lead in the delivery and project management processes required to complete the project within timeline and budget.
- Generate and/or Review equipment specifications, owner project requirements, specifications, checklists, and test data as required.
- Document, monitor, and report on project deliverables
- Manage project documentation such as protocols, reports, calibration certificates, and process trends.
- Ability to provide self-direction, detail oriented, 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.
- Communicates project objectives, scheduled timelines, progress updates and project risk factors to Engineering Department Manager.
Who You Are:
- Bachelor of Science preferred
- Equivalent experience in lieu of education will be evaluated.
- Applicant must have a basic working knowledge of production and engineering support principles and concepts, including a professional understanding of best practices, techniques and standards
- 4 plus years of experience in Pharmaceutical/ Biotech in an Engineering, Commissioning, Validation or QA role
Knowledge and Skills:
- Expert knowledge of utilities, systems and equipment in support of biopharmaceutical manufacturing processes:
- HVAC, Chilled Water Systems, Heating Hot Water Systems
- Purified Water Systems, WFI, Clean Steam
- Autoclave/Steam Sterilization Systems
- Bioreactor Systems
- Chromatography Systems
- Controlled Temperature Units (CTUs)
- Excellent computer skills, i.e., Word, Excel
- Good verbal and written communication skills
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 come2emd.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 his/her Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because he/she made a good faith report of discrimination.