Operations Microbiologist

**THE OPPORTUNITY**

As a Senior Specialist Operations Microbiologist, you will provide technical microbial and aseptic process support and expertise to the Sterile Integrated Process Team (IPT) in accordance to meeting the Priorities of: Compliance, Supply, Strategy and Profit Plan. You will be working closely and to provide technical solutions to the IPT team to support a High-Performance Organization. You will be an active member within the IPT Team providing support, guidance and striving for Aseptic excellence to ensure the success of the IPT.

**WHAT YOU WILL DO**:
Reporting to the hiring manager, you will provide ongoing coaching and support to the IPT team members, to share their aseptic technical knowledge and promote best practices, coaching on GMP requirements and regulations. Other responsibilities include:

- IPT representative on Microbiological and aseptic processing technical agenda
- Collaborates in the development and execution of the Facility-based Environmental Monitoring programs.
- Provides aseptic guidance on facility and process-related controls and changes.
- Lead investigation for microbial contamination event within biotech IPT
- Front microbial and contamination control topics for internal and external audits
- Collaborate with compliance team for pre
- and post-audit action.
- Responsible for the preparation, review and approval of relevant technical documentation, risk assessments, CCP, CCS etc.
- Ensure the highest Quality, Compliance and Safety standards.
- Lead, participate and comply with our Quality Management System (QMS) requirements, related to QSIP implementation program for IPT.
- Lead continuous improvement projects related to aseptic and cross contamination control strategy that will enable key success to plant Hoshin plan.
- Carry out specific administrative tasks as instructed by the operation management.
- Any other duties as and when assigned by the Manager.

**ABOUT YOU**:
To be successful in this role you should possess a Degree in Science/Quality or equivalent, with at least 8 years of experiences in Aseptic processing, Microbiology and pharmaceutical manufacturing. Other skill set include:

- Working knowledge of regulatory expectations of Aseptic processing in the Biotechnology industry.
- Strong analytical and technical skills.
- Demonstrated high level of problem solving and facilitation skills - resolution and prevention measures.
- Demonstrated self-motivation/direction skills with a continuous improvement focus.
- Demonstrated ability to lead and realise improvement initiatives.
- Demonstrated successes in a team environment, such as project teams, Six Sigma teams, Cl teams etc.
- Excellence technical writing skill which provides clarity, conciseness, accuracy, and the ability to effectively communicate complex information.
- Effective engagement and management of stakeholders to ensure project and actions completion.

**Who we are**

We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

**What we look for**

Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.

**Search Firm Representatives Please Read Carefully**

**Employee Status**:
Regular

**Relocation**:
**VISA Sponsorship**:
**Travel Requirements**:
**Flexible Work Arrangements**:
Not Applicable

**Shift**:
**Valid Driving License**:
**Hazardous Material(s)**:
**Job Posting End Date**:
09/19/2024

**Job Posting End Date**:09/19/2024

**Requisition ID**:R310346