Operations Microbiologist

Job Description

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

• Member of Aseptic facility design and control teams, in areas such as HVAC design and application.

• 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.

• Highly motivated and interested in bringing current microbiology research and technology platforms toward a biopharmaceutical operations application.

• 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.

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Job Posting End Date:09/09/2024

A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID:R310346