Packaging Technical Operations, Specialist, Engineering

Job Description

New Hires based in the US & Puerto Rico will be required to demonstrate that they have been fully vaccinated for Covid-19 or qualify for a medical or religious exemption or accommodation to this vaccination requirement, subject to applicable law.

Are you looking for an exciting opportunity with a rapidly growing pharmaceutical manufacturer? If so, then this is the opportunity for you!

Our Engineers support internal and external manufacturing operations remain operational, continuously improve and innovate. With our extensive range of facilities and environments, our Engineers have opportunities across many diverse areas including Biological, Chemical, Automation, Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities and Validation.

West Point Technical Operations is seeking highly motivated individuals to provide engineering technical support for a vaccine packaging facility. The focus of the role includes Deviation Management, Product Quality Complaints, and one or more additional areas of responsibility to include Packaging Artwork coordination, process improvement projects and floor support, equipment/serialization/product launch projects involving the Change Request process, and management of the update of Packaging Master Batch Records.

The deviation management role includes investigation of process deviations (i.e. identifying root cause, recommending corrective/preventative actions, assessing product impact, and summarizing investigations in writing). The product quality complaint role includes investigation of complaints from distributed product (i.e. analyzing samples, reviewing batch data, identifying root cause, assessing impact, and summarizing investigations in writing). The other areas of responsibility offer opportunity for further development and rotation to gain experience in different potential functional roles within Technical Operations. Limited additional shift or weekend coverage may be required based on specific assignments.

The individual in this position will be responsible for the following:

• Performing deviation investigations aimed to prevent deviation recurrence, including determining the root cause, identifying corrective/preventative actions, identifying event scope, and conducting product impact assessment. Where applicable, complete investigational test protocols to determine root cause, product impact, event scope, etc.

• As required, manage the IPT deviation management daily huddle to evaluate potential deviations, facilitate the discussions to align with technology and quality approvers / representatives on deviation classification and impact assessment.

• As required, manage the weekly complaints huddle to facilitate the discussions to align with technology and quality approvers / representatives on complaint resolution.

• Providing on-the-floor support of operational and technical issues; providing immediate responses on the shop floor to deviations and potential deviations.

• Collaboration across IPT functional areas to drive robust processing and continuous improvement. Continuous improvement may include proactive process improvements, investigation Corrective/Preventative Actions (CAPAs), or value capture projects that seek to improve yield, reduce cost, or lower cycle times.

• Supporting team and IPT safety, environmental, and compliance objectives.

• Managing investigation, change request and project timelines to ensure key compliance and customer due dates are met; escalating any potential misses and develop remediation plans when possible.

• Actively using and championing the use of Production System tools, both in problem solving and day-to-day operational activities.

• Authoring and updating technical and manufacturing documents necessary for investigations, process design/definition, engineering studies, process demonstrations, change control and validation

• Authoring notifications to applicable Health Authorities, in response to deviations or complaints, as required.

• Supports and/or executes continuous improvement projects that increase compliance, simplify/ standardize and/or gain efficiencies.

• Provides technical support to manufacturing for complex problems and issues including process/equipment.

• Collaborates effectively with the area Operators/Mechanics, support groups, Quality, and Planning.

Required Education / Experience:

• Bachelor's degree in chemical engineering, mechanical engineering, biological sciences, packaging or related discipline.

• Packaging or vaccine/pharmaceutical manufacturing experience (Operations, or Technology)

• Technical writing (e.g. investigations, technical protocols/reports)

Strongly Preferred Experience

• Minimum 1-year experience in Deviation management and/or Complaints.

• Trackwise, MIDAS, SAP

• Investigative tools (e.g. 5-whys, fishbone).

• Experience in applying Production System tools and mindset, both in problem solving and day-to-day operational activities

Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of bio-pharmaceuticals 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., 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 …

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.

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:

EEOC Poster

EEOC GINA Supplement​

OFCCP EEO Supplement

Pay Transparency Nondiscrimination

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.

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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

Requisition ID:R161654