Specialist, Engineering

Job Description

Job Description

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.

Durham’s Technology Specialist will be an energetic, technical leader with strong interpersonal, communication, and collaboration skills responsible for the implementation of technology transfer process knowledge, post-approval support, and post commercial process enhancements activities for pipeline vaccine programs. This is position will primarily support vaccine drug substance site readiness and technology transfer in the Sterile Supply and Alum Manufacturing areas.

Additionally, this role will contribute to the performance and results of a department, provide technical guidance, and anticipate and interpret client and/or customer needs to identify and implement solutions. The role encompasses technical services support in the areas of equipment and automation systems, validation, deviation management, and product franchise.

Responsibilities

• Primary support of Alum Manufacturing suites with additional support in the Sterile Supply area related to the vaccine drug substance
• Provide technical/team support for FAT, equipment installation, SAT, and commissioning/qualification/validation activities
• Actively participate on cross-functional manufacturing teams to advance projects goals and deliverables related to the vaccine process
• Lead technical studies and author documentation associated with equipment and process shakedown activities
• Support initial process simulation activities to enable transition into subsequent sterile process development and qualification
• Support technical studies including engineering runs, stability and ultimately process validation activities
• Provide deep SME knowledge for manufacturing investigations support (Product and process deviations and complex material-related)
• Collaborate with internal/external partners, e.g. Other company sites, Procurement, Raw Material & Component Suppliers
• Develop effective data analytics methodologies, including statistical process control, deepening process understanding
• Author, review, and/or edit technical documents to support regulatory filings including technical reports and risk assessments
• Author Change Control documentation for a complex process, validation, analytical, equipment, facility/utility and/or automation changes. Managing on-time implementation and close-out to meet project, production and supply timelines.
• Support aspects of regulatory inspections by presenting and defending technical documentation, investigations, and change controls
• Evaluate and develop innovative process technologies, continuous process improvements and post-launch process enhancements
• Provide post-approval support and subject matter expertise support to ongoing manufacturing activities

Education Requirements

• Bachelor Degree in Engineering or Sciences with a minimum of two years of relevant experience or a Master of Science Degree

Experience and Skills

Required

• Vaccine or biologics manufacturing
• Authoring technical documentation
• Proven leader with influence and outstanding communication (written & presentation) skills
• Project strategic plan development and management

Preferred

• Bulk upstream and/or downstream vaccine processes within a cGMP environment
• Clean-in-Place and Sterilize-in-Place systems
• On-the-floor cGMP manufacturing support including providing immediate responses on the shop floor to deviations and supply interruptions
• Authored process change control
• Authored deviation investigations
• Validation documentation and execution
• SAP | Manufacturing Execution Systems (MES) | Delta V
• Process risk assessment tools
• In Person presentation of technical subjects to regulatory inspectors

Schedule Requirements

• Off-shift and weekend coverage will be required based on business unit needs and specific assignments

Travel Required

• 10%

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., 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.

Residents of Colorado

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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.

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:

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Travel Requirements:

Flexible Work Arrangements:

Shift:

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Hazardous Material(s):

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Requisition ID:R149052