A career with MilliporeSigma is an ongoing journey of discovery: our 56,000 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.
Your role will include process validation, test method validation, and cleaning validation execution, data analysis, and report writing. As Subject Matter Expert, you will be troubleshooting lab instrumentation and a wide range of test methodologies. Sitewide support as needed to support the plant for system and product failures. Providing guidance for trouble-shooting instrumentation and methodologies related to LAL Endotoxin, Total Organic Carbon (TOC), Fourier Transform Infra-Red (FTIR), Gel Permeation Chromatography (GPC), Conductimetric Karl Fischer, UV-VIS Spectroscopy, Raman, etc.
- Execution of and documentation of analytical data related to process validation, test method validation, and cleaning validation. Managing all annual qualification reports for instrumentation in scope.
- Maintenance of critical standards and reagents needed for Dextran testing—expiry and procurement, including identification and validation of new vendors and new lots as required. When necessary, fully participate on teams managing supplier and reagent supply issues that may require changes in multiple product test specifications.
- Support customer, internal, and divisional audits as Subject Matter Expert.
- Support and contribute to improvements in Data Integrity aspects of testing equipment to include validation of vendor software upgrades
- Support plant as a Subject Matter Expert for system and product failures as well as plant initiatives for enhanced product specifications.
The world-class Jaffrey Manufacturing Center of Excellence is ISO 9001 and ISO 14001 Certified, practices Six Sigma principles and is an environmentally conscious facility focused on long term sustainability. Our lab primarily supports testing the membrane manufacturing operation which produces membrane used for the purification and concentration of therapeutic proteins, recombinant and non-recombinant proteins, solutions containing albumin, hormones, vaccines, and growth factors. We also produce a virus barrier membrane designed to simultaneously deliver high parvovirus retention, capacity and flux.
Who you are:
- Bachelor’s degree in Chemistry or related discipline
- 5+ years’ experience in a pharmaceutical laboratory or GMP and GLP regulated environment
- 5+ years’ experience utilizing technical writing, communication, and analytical 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
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.