A career with MilliporeSigma is an ongoing journey of discovery: our 50,000 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.
In this role you will be you responsible for:
- Oversight of the facility Microbiological Environmental Management programs.
- Performing the testing and/or coordination related to the environmental monitoring program, product analysis, product stability analysis and related testing in the Microbiology Laboratory in compliance with established laboratory procedures, cGMP and any other established internal or external procedure and policies.
- Monitoring the performance of the site gowning and cleaning and sanitization programs.
- Performing laboratory analysis or tasks following established procedures and in full compliance with current governmental regulations, official compendia and any other policy / regulation to generate reliable and timely results, to comply with releases due date, reducing cycle time, and providing internal/external customer satisfaction.
- The analysis consists of: bacterial endotoxin, sterility test, bioburden / microbial limit, growth promotion, particulate matter to parenteral products, microbial identification and other analysis related to the release of the products being manufactured. In addition to microbial analysis of: manufacturing utilities (i.e. water, clean condensate, compress air, nitrogen, etc.),Â
- The tasks will be: preparation and sterilization of materials needed for the analysis, such as culture media and the depyrogenation/sterilization of glassware. Environmental surveillance of aseptic manufacturing and packaging facilities which includes viable (air, surface personnel) and non-viable monitoring.Â
- Generating environmental trends and graphs of the controlled environments
- Training the manufacturing personnel in environmental monitoring sampling and other aseptic processing techniques.Â
- Generating Microbiology Laboratory Investigations Reports (MLIR) and assist in the investigation of out of levels, out of limits and out of trends.Â
- Operating laboratory equipment (such as air viable monitoring instruments ; non-viable monitoring devices for particulate matter analysis,; microscopes; Laminar Flow Hoods and Biosafety Cabinets for the handling of biohazardous material; autoclaves;other microbiology laboratory equipment).Â
- Maintaining accurate records of all work performed and document test results as per Good Documentation Practices. Maintaining laboratory logbooks and worksheets as per cGMP requirements.Â
- Maintaining a safe work environment and use required safety equipment.Â
- Executing test method, process validation and equipment validation test as per corresponding protocols.Â
Who you are:
- You have at least a BS in Microbiology (or similar); MS in Microbiology (or similar) preferred
- You have 3 + years of experience within the pharma/biotech industry within a technical capacity
- You are analytical, curious, and have the ability to learn beyond expertise using step by step logic
- You are also a strong conceptual thinker, can see beyond just the obvious, and have the ability to understand the various functions of the industry.
- You are a good technical writer / communicator, are process oriented, and have strategic understanding
- You preferably have a basic level understanding of biostatistics. Also, experience with Minitab, Excel, SPSS, or other Statistical Software is desired
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.