Operations Support Engineer

Job Description

Our Manufacturing Operations teams are the people that make our products. We work in the manufacturing plants with a “Safety First, Quality Always” mindset striving for continuous improvement. We work in the local plant connected to our global manufacturing network to ensure the highest quality of raw materials, intermediates and finished products.

We are recruiting for an Operations Support Engineer position within the Monoclonal Antibody/ Cell Culture Department. The Operations Support Engineer, in conjunction with the execution routine production activities, will primarily support the team by acting as a Subject Matter Expert (SME) representing their department in support of continuous improvement, problem solving and deviation and change management.

The basic purpose of this position is to provide expert support for our Company Animal Health antigen production operations at our site in De Soto, Kansas. This position provides technical support to assure that manufacturing schedules are met in a compliant manner with safety, quality, and regulatory requirements. Responsibilities include that antigen products specifications are met prior to release for compliance to product Outlines, United States Department of Agriculture 9 Code of Federal Regulations, and cGMP. The scope of support includes every manufacturing stage from raw materials through final antigen product.

Responsibilities:

Employee Development & Leadership

• Models Company leadership principles and inclusive behaviors

• Provides coaching and supports skills development and process capabilities within their team

• Supports effective feedback and coaching within the team during the Performance Management cycle

• Providing appropriate task-based training

Safety Compliance

• Demonstrates a strong compliance mind-set (EHS and Quality) and continuously sets a high standard for themselves and others

• Follows safe operating instructions for all tasks and equipment

• Ensures that the right tools and equipment specified for the task are available and utilized

• Ensures that the correct personal protective equipment required is available and utilized

• Follow up any reported defects or workplace hazards immediately

• Report all accidents, incidents and near misses within 24 hours and to participate in investigation and identification of effective corrective and preventative actions

Quality Compliance

• On-time completion of Quality compliance tasks in relation to Deviation, CAPA and Change Control management.

• Quality Assurance including cGMP, RFT and good documentation practices and provides coaching to others.

• Change Manager and Stakeholder for change management activities within Production.

• Supports the update, review and approval of GMP documentation including, but not limited to: SOP’s | MD’s | Qualification Protocols | New product/product transfer documentation

Productivity and Financial

• Supports the Daily, Weekly and Monthly schedule adherence of production activities within their department

• Build and maintain strong collaborations with different stakeholders throughout the Site Operations such as BTS, Engineering, Quality and R&D

• Supports the Manufacturing Operations Teams in creating a culture of continuous improvement and leads by example

• Represents Manufacturing Operations in the execution of the project portfolio and improvement initiatives

• Supports initiatives for stabilizing and improving production processes

• Assures effective application of Lean Six Sigma, Project Management and Change Management Tools

• Supports Manufacturing Operations key productivity metrics by investigating and solving operations issues with appropriate techniques and skills

• Contributing to a data driven decision making process and visualizing problems, progress and results

• Recognizes and investigates opportunities for financial savings

Education Requirements:

• Required | High School Diploma plus three (3)+ years of experience working in a Pharmaceutical Manufacturing role

• Preferred | BSc Degree in a relevant scientific discipline plus experience working within a Pharmaceutical Manufacturing role

Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of biopharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network that’s devoted 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., 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.

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.

Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

For more information about personal rights under Equal Employment Opportunity, visit:

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We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

Learn more about your rights, including under California, Colorado and other US State Acts

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):

Requisition ID:R230468