Aseptic Processing Lead

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.

Your Role:

As the Aseptic Processing Lead at MilliporeSigma in Carlsbad, CA you will be a Subject Matter Expert (SME) for development, implementation, monitoring and improvement of Sterility Assurance process and systems. You will evaluate manufacturing operational practices and strategies to ensure compliance with regulatory requirements, lead, develop, implement, and influence changes to meet these requirements and continuously improve sterility assurance processes. You will be responsible for training, coaching, and qualification program for aseptic techniques, behaviors, and gowning.

Responsibilities:

• Oversight of the sterility assurance program at the Carlsbad facilities and sharing sterility assurance best practices at other MilliporeSigma aseptic manufacturing sites
• Evaluate manufacturing operational practices to ensure compliance with regulatory requirements, identify risk and implement changes to meet requirements
• Management of the Aseptic processing training program, including new employee training, routine annual training, and retraining. The role includes management of the Cleanroom operator qualification Program
• In collaboration with the validation team, develop and evaluate PQ validation studies to demonstrate facilities are adequately designed and operated for sterility assurance
• Overseeing aseptic simulations (media fills) and smoke studies, facility cleaning, site aseptic behavior, and site gowning programs. Maintain and improve SOPs for each of these programs
• Evaluate material transfer practices and critical intervention behaviors for compliance to aseptic regulations and continuous improvement
• Act as SME and interface directly with domestic and foreign regulatory inspectors regarding microbiological and sterility assurance topics
• Accountable for the evaluation and closing of Aseptic Processing Investigations, change control, corrective action, and preventive action (CAPAs) in a timely manner
• In conjunction with the Site leadership team conduct periodic review of sterility assurance programs (facility cleaning, material transfer, gowning, and aseptic simulations)
• Provide technical guidance for all questions and issues related to sterility assurance, aseptic processing, RABS/isolators, material transfer, room fumigation, and cleaning
• Interface directly with manufacturing operations to ensure that appropriate environmental and aseptic procedures are in place. Provide oversight and measure effectiveness of sterility assurance programs
• Participate in the Environmental Review meetings and liaise with the QC department in the assessment of environmental trends
• Support the clean room qualifications and re-qualifications
• Provide technical guidance for all questions and issues related to sterility assurance, aseptic processing, RABS/isolators, material transfer, room fumigation, and cleaning

Minimum Qualifications:

• Bachelor's Degree in Microbiology, Biology, or related life science
• 5+ years of experience in a GMP environment working with environmental monitoring of aseptic processing and sterility assurance systems

Preferred Qualifications:

• Experience in training and coaching of aseptic techniques and training of aseptic personnel on microbiological principles and techniques related to aseptic operations
• Extensive knowledge with cGMP governmental regulations and guidelines, and the ability to interpret and apply them
• Theoretical knowledge of microbiology and contamination control

• Demonstrated experience in developing, implementing and maintain robust sterility assurance programs including aseptic technique within cleanrooms, facility cleaning and disinfection, bioburden control and environmental monitoring
• In depth understanding of validation process associated with sterility assurance, such as but not limited to, media simulations, cleanroom qualification and classification, autoclaving, isolator qualification and fumigation
• Experience with RABS/ isolator technology and single-use-systems
• Advanced practical knowledge of cleaning, gowning, aseptic behaviors, material transfer, aseptic simulation, and environmental monitoring programs required to influence global decision making, regulators, and stakeholders
• Experience with providing leadership to generate options, resolve problems, prioritize solutions, select optimal solutions, and implement decisions
• Demonstrated interpersonal and leadership skills. The ability to function and influence within team-based organization

• Strong communication skills and strong technical writing and interpretation skills related to investigations and Regulatory Filings

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!

Our Benefits - http://jobs.vibrantm.com/emd/content/Benefits-at-a-Glance/?locale=en_US

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.