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Principal Quality Engineer
A career with MilliporeSigma is an ongoing journey of discovery: our 58,000 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. 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.
US employees must be fully vaccinated against COVID-19 prior to your start date unless an accommodation is granted by The Company. The Company uses the definition of fully vaccinated assigned by the Centers for Disease Control & Prevention for purposes of considering satisfaction of this requirement which is a condition of employment.
As a Principal Quality Engineer, you will be responsible for the QA oversite, review and approval of Facilities Engineering, Process Engineering, and Validation Activities including facilities, utilities, and equipment specification, commissioning, validation, calibration, maintenance, validation, and data integrity/computerized systems compliance. You will be a primary Quality contact at the Carlsbad Site for internal QA support of facilities for our contract manufacturing business. This will include developing and driving appropriate performance KPIs, managing timelines and working with various stakeholders to successfully deliver customer deliverables, while helping to maintain our facilities in a state of inspection readiness. You are responsible for ensuring all the activities follow established SOPs and regulations as well as meeting current compliance requirements(cGMP).
Additional responsibilities include:
- Ensure that Quality metrics are met and continually improving, and that metrics are communicated throughout the site as appropriate.
- Review and approve protocols and final reports.
- Liaise with appropriate cross-functional departmental areas to determine root cause for non-conformances.
- Contribute ideas and suggestions to improve Quality systems, Compliance and Safety.
- Participate in internal and external interactions such as client and regulatory audits/inspections, meetings, teleconferences as the QA expert.
Who You Are:
- BS degree or higher in a Life Science discipline or related field.
- 10+ years of experience in cGMP Quality Assurance environment.
- Experience in quality oversight for facilities, engineering, and validation.
- Strong foundation in quality systems supporting FDA and EU regulations.
- CMO experience is a plus.
- Knowledge of governmental regulatory guidelines relating to the manufacturing of biologics and pharmaceuticals.
- Experience with Lean Manufacturing and Continuous Improvement concepts.
- Strong interpersonal skills and ability to work with a variety of personalities at all levels within the organization.
- Detail oriented with strong written and verbal 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 https://jobs.vibrantm.com
If you are a resident of a Connecticut or Colorado, you are eligible to receive additional information about the compensation and benefits, which we will provide upon request. You may contact 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday, for assistance.
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.