Job Information
Actalent Sterility Assurance Specialist in Brownsburg, Indiana
Sterility Assurance Specialist - Brownsburg, IN
INTERESTED IN THIS ROLE? Apply and reach out TODAY directly to Grace Williams for immediate consideration with an updated resume grawilliams@actalentservices .com
Overview:
A fast-growing clinical stage biotech company focusing on the development of targeted alpha therapy (TAT), an innovative class of pharmaceutical agents to combat cancer. Based on strong preclinical and clinical results, is preparing for the commercialization of its products. Actively seeking a Lead Microbio Sterility Assurance Specialist who is willing to take responsibility and grow within their new state-of-the-art facility for commercial-scale, sterile manufacturing of therapeutic radiopharmaceuticals.
The Sterility Assurance Specialist is responsible for maintaining sterility assurance processes and ensuring compliance with industry standards and regulations. They collaborate with cross-functional teams to develop and implement bioburden reduction strategies, perform risk assessments, and address microbiology-related issues.
Key Responsibilities:
1) Technical Expertise:
Overseeing the Sterility Assurance Program and a lot of the work that happening. Primarily managing the program that’s already designed but needs implemented and managing moving forward. Looking at environmental monitoring data/trends, run the tests, studies, etc. to ensure sterile environment.
Be a subject matter expert in sterility assurance in interactions with regulatory bodies (such as the FDA), notified bodies, and customers.
Develop responses to microbiology and sterilization-related requests and audit findings.
2) Risk Assessment and Root Cause Analysis:
• Conduct risk assessments related to sterility assurance and microbiology.
• Perform root cause analyses for sterility assurance, environmental monitoring, and other microbiology-related issues.
• Develop corrective and preventive actions to address identified risks.
3) Compliance and Standards:
• Maintain compliance with relevant regulations (e.g. 21 CFR Part 210/211).
• Ensure adherence to industry standards and best practices.
• Collaborate with internal and external stakeholders to align processes with guidelines.
4) Quality Control and Audits:
• Regularly audit personnel and processes for bioburden control and sterility assurance.
• Manage and evaluate ISO classification activities, media fills, and gowning validation processes
• Perform trending and analysis of environmental monitoring and other microbiological data for management review and continuous improvement
5) Team Leadership and Training:
• Provide guidance, training, and support as needed to operators in support of aseptic and sterile operations.
• Foster a culture of quality and compliance within the team.
6) Skills:
Aseptic, Quality Assurance, Sterility, Process improvement, Batch Record, cGMP, Cyclotron, Particle Accelerator, Sample Prep, Clean Room, radiopharmaceutical, nuclear medicine, isolator, sterile environment, sterile manufacturing
CAPA, Deviation, SOP Review, Document Review, Technical Writing, Batch Release, Cleanroom, Risk Assessment, Risk Analysis, Laboratory, SOP Writing, SOP Development, Sterility Assurance, Pharmaceutical, Injectables, ISO 7, ISO 8
Bioburden, Aseptic Technique, Microbiology, Microbiological, Environmental Monitoring, Quality Control
Qualifications:
1) B.S. or B.A. Degree in Life Science or related field (Microbiology or Biology Preferred)
2) 1+ year of experience working within clean rooms or an aseptic environment (any pharma, with Sterile Liquid Injectables being the most relevant)
3) 3+ years of strong Sterility/Microbiology experience (Bioburden, environmental monitoring, aseptic technique, media fills, etc.)
4) Independent, strong communication skills, take initiative, fast pace, wear multiple hats, etc.
Nice To Have but Not Required:
1) Radiopharmaceutical experience
2) FDA Submission (IND, DMF, NDA)
3) Software: eQMS, eBR, LIMS, BMS
4) New facility: new systems, construction, qualification
Soft Skills Requirements:
• High-pressure environment with same-day deadlines; work with urgency
• Challenging technical problems
• Strong attention to detail; meticulous documentation
• Adaptable: similar output and quality of work under direct supervision, working in a team, or working independently
• Efficient and clear oral/written communication; answering questions
• Collaborating with cross-functional teams
• Very organized workspace/style
INTERESTED IN THIS ROLE? Apply NOW
I am actively hiring for this position and conducting phone interviews as early as today. All candidates will be considered immediately and bypass the HR process to be in consideration within 24 hours of applying and reaching out directly TODAY to Grace Williams.
HOW TO APPLY: Email your updated resume, brief intro about your interest, what method of communication works best for you (i.e., call, email, text) to grawilliams@actalentservices. com or call (317-567 -6610)
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & Inclusion
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
Hiring diverse talent
Maintaining an inclusive environment through persistent self-reflection
Building a culture of care, engagement, and recognition with clear outcomes
Ensuring growth opportunities for our people
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.