Job Description

Job Description

Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network committed to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.

The Quality Operations Environmental Monitoring Subject Matter Expert works within quality and with other teams to manage environmental monitoring for finished antibiotic processing, bulk sterile API processing and vaccine/therapeutic protein processing. This position is responsible for oversight of the environmental monitoring programs for the site including cGMP compliance, review of data, atypical resolution with production, trend analysis, cost and time reduction initiatives, training, audits, and troubleshooting. In addition this position will also work with our Company global Network as a representative of the site on Environmental Monitoring related topics.

Position Responsibilities:

* Ensure that microbiological environmental monitoring and analysis is performed according to Divisional Guidelines and adheres to all applicable regulatory requirements. Program includes surface, air, personnel, and cleaning

* Extensive involvement in internal and external regulatory audits.

* Responsible for training and development of site staff as well as documentation and corrective actions related to deviations and excursions.

* Assists production as technical expert related to requirements for testing of classified areas.

* Routinely evaluates the trends of microbial counts and growth, prepares written environmental microbial data summaries as required

* Initiates and leads environmental monitoring investigations to evaluate personnel gowning practices, equipment cleanliness/sanitization, and cleaning operations including physical construction of the room and performance of the HVAC system.

* Ensure that the reporting of data and maintenance of records is performed as per Division Guidelines. Also, that the interpretation of the data is correct and that the results are effectively communicated to appropriate individuals/workgroups.

Required Experience and Skills:

* Bachelors or advanced degree in Microbiology, Biology, or Environmental Science and/or Engineering

Required Experience and Skills:

* Minimum of three years experience in aseptic production processes required, with experience in environmental control, or microbiology preferred.

* Technical knowledge related to environmental monitoring, sterilization methods, microbial physiology, disinfection/sanitization methods, current good manufacturing practices and an understanding of aseptic handling procedures.

* Evidence of leadership skills coupled with good oral and written communication skills.

* Requires knowledge of Microsoft excel, power point and word.

* Requires good written and verbal communication skills.

Preferred Experience and Skills:

* Familiar with CFR, cGMP, ISO, USP/NF, EP and JP regulations.

* Familiarity with USP Chapters on EM and Utilities and Industry best practices such as PDA white papers

Our Manufacturing & Supply Division is committed to be the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create an interdependent global manufacturing network thats committed to delivering a high quality, reliable supply to customers and patients on time, every time.

Who we are

We are known as Merck & Co., Inc., Kenilworth, 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

In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.

INVENT.

IMPACT.

INSPIRE.

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

US and Puerto Rico Residents Only:

If you need an accommodation for the application process please email us at staffingaadar@msd.com
For more information about personal rights under Equal Employment Opportunity, visit:

EEOC Poster

EEOC GINA Supplement

OFCCP EEO Supplement

OFCCP Pay Transparency Rule

We are an equal opportunity employer, Minority/Female/Disability/Veteran proudly embracing diversity in all of its manifestations.

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, 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:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Not Specified

Shift:

1st - Day

Valid Driving License:

Yes

Hazardous Material(s):

Number of Openings:

1
Requisition ID:R80243