Process Microbiologist in Barnahely, CO

Summary

• Reporting into the Snr Plant Microbiologist the Operations microbiologist is responsible for Active participation in the microbiological control and assurance program within the operations department.
• Managing activities in compliance with corporate, cGMP, EHS, and other regulatory requirements.

The responsibilities & the impact YOU will have:

• Lead by example and striving to perform to high standards at all times in compliance with Credo and Standards of leadership.
• Perform all activities in compliance with corporate, cGMP, EHS, and other regulatory requirements.
• Actively lead / support process microbiological investigations.
• Perform routine area walkdowns / GEMBA’s.
• Support and drive strategy improvements related to the reduction of contamination risks and the improvement of microbiological hygiene through the promotion of a culture of continuous improvement and open communication.
• Perform Risk Assessments for operations projects and business innovation initiatives
• Define specific aseptic techniques to be performed for crucial process steps
• Support periodic review of environmental monitoring and in-process sampling trends and identifies appropriate corrective and preventative actions as required.
• Provide effective and timely communication of any adverse trends or activities as appropriate.
• Achieve individual goals through actively working with departments and individuals
• Maintain customer focus to deliver business requirements.
• Collaborate with Process Microbiologists internally and across the Client network
• Access global microbiology support resources, as required.
• Review and approve relevant SOP’s and WI’s.
• Participate in the planning for future requirements in Operations.
• Ensure microbiological control strategy is consistent with GMP requirements and company requirements.
• Participate in relevant internal and external manufacturing related audits.
• Understand and support current regulatory trends and future testing requirements.
• Deputize for the Microbiology team, as required
• Comply with EHS rules and procedures at all times.

We would love to hear from YOU, if you have the following essential requirements:

ESSENTIAL:

• BSc in a scientific/technical discipline required.
• Ideally microbiology discipline
• Minimum of 5 years of experience within a pharmaceutical or GMP regulated Operations environment.
• Possess knowledge and experience of the shop floor manufacturing process.
• Possess knowledge of data analytics
• Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals.

DESIRABLE:

• Validation experience within a Life Sciences or Biopharmaceutical manufacturing environment
• Business Excellence and Problem Solving skills Qualifications e.g. Six Sigma, Lean Green/Black Belt or Kepner-Tregoe analysis.
• Advanced degree (MS, MBA, PhD)

This is what awaits YOU at Client:

• This is an opportunity to work with a groundbreaking biomedicine operation and to be a member of a Client company, with an excellent record in employee continuous professional development and business improvement.
• We are passionate about our work; we play vital roles across a range of professional disciplines and care deeply about our customers and communities.
• At Client our culture enables dynamic and impactful careers.
• Whether you’re one of the people who already work here, or you’re considering joining the team, we offer:
• An opportunity to be part of a global market leader.
• A dynamic and inspiring working environment.
• Opportunities to work on challenging projects and assignments.

Rangam Consultants is a minority, women-owned, disability workforce solutions global organization. We specialize in attracting and retaining talent globally for rewarding careers in IT, Engineering, Scientific, Clinical, Healthcare, Administrative, Finance, Business Management, and many more, while integrating veterans and individuals with disabilities into the workforce. Indeed, we connect career aspirants to relevant job opportunities, whether in the USA, UK, India, or Ireland. Additionally, we offer Location Independent jobs and contract positions across different verticals and industries.
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