Job Detail

JOB DESCRIPTION

Job Description

The Senior Specialist - Engineering will be the key technical leader interface between our company and External Partner for the Large Molecule Vaccines External Manufacturing (ExM) organization.   This individual will create, lead and execute technical transfer(s) to and commercial supply for our company’s Vaccine(s) from External Partner(s).    The candidate will be based in Switzerland and report to the “Director, Large Molecule (LM) External Manufacturing Technology”.  This role is critical to the organization’s ability to support in-line commercial product technology transfers of vaccine drug substance to External Partner, and support of our in-line products, with sharp oversight and technical risk management. 

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.  

Job Details:

The primary focus of the Senior Specialist is to provide technical and project leadership to Large Molecule Vaccines External Manufacturing business for:

• New manufacturing facility startup, including but not limited to person-in-plant support, directly within the new EP manufacturing facility:
  
  
  
  • review manufacturing documents including batch record check, standard operating procedures, job aids, and protocols
  
  
  • process troubleshooting,
  
  
  • support manufacturing investigations, and
  
  
  • review analytical results
  
  


• Support Water Runs, Equipment shakedown runs, Engineering Runs, and Process Performance Qualification (PPQ).


• Collaborate across multiple technical functions within our company and the EP team to ensure the successful technical transfer and commercial manufacture


• Author process change control documentation, technical communications, and process risk management


• Provides a single point of technical contact to assigned External Partners, impacted sites of our Manufacturing Division, and Commercialization. 


• Provides technical oversight, management, and planning support for complex partnership models.  Functions independently and provides coordination, communication, and oversight of assigned External Partner technical issues


• Accountable to External Manufacturing for overall tech transfer delivery (on-time, within budget), working closely with the Operations Unit leadership to assure resourcing for each activity.


• Provides technical guidance to the External Partner, assess viability of technology in proposed process configurations, verify adherence to required standards, and ensure deliverables are technically sound. 


• Ensures tech transfers are positioned for successful business outcomes.   Executes technical transfers and receiving site readiness activities.


• Leads team for identification and assessment of partner risks and develops mitigations plans. 


• Develops and executes validation strategies for new and existing products.


• Provides manufacturing process support to External Partner(s) to resolve production issues and to provide guidance on process and capacity optimization.   


• Support/Coordinate/Manage complex investigations, with appropriate interface with other impacted manufacturing sites


• Provides a technical review of External Partner process change requests, deviations, and Master Batch Record changes.  Minimizes duplication of efforts between External Partner and our company’s systems.


• Drive and support Continuous process verification and process performance monitoring program for all products under his/her responsibility


• In concert with Operations, Quality, and Regulatory, ensures that External Partner(s) are inspection ready for all new product introductions and transfers.


• Understands the true regulatory requirements and partners with Operations, Quality, and the External Partner to develop more efficient ways to meet these requirements. 


• Collaborates with External Partners to achieve business goals and to establish a common culture that benefits both our company and EP.

Education Requirements:

A Bachelor’s degree in Engineering or applicable Science is required.  An advanced degree in Engineering, Science, or Business is preferred.

Skill Requirements:

• Minimum of 6 to 8 years post-bachelor’s degree experience in Vaccines Drug Substance and/or Drug Product vaccines manufacturing, engineering, and/or technical support of operations is required


• Vaccines drug substance fermentation manufacturing experience is required


• Advanced problem-solving skills and experience leading teams to resolve complex business or technical issues is required


• Excellent leadership, collaboration, change management, interpersonal, analytical skills, collaboration, and engagement as a team player with dependable interpersonal and communication skills (both verbal and written) is required. 


• Experience in leading cross-functional teams in support of manufacturing operations at internal sites or External Partner(s) is preferred


• Expertise and demonstrated accomplishments with Lean Manufacturing applications to ensure year on year productivity improvements is preferred


• Ability to motivate a team around a common vision and deliver expected results is preferred.


• Creative, innovative, thinks outside of the box, self-motivated, applies problem-solving skills, and solid base in engineering fundamentals and process troubleshooting is preferred


• Experience in complex international environment with matrix organization structures is preferred


• Experience in Large Molecule unit operation design, startup, and/or operation is preferred. 

Travel Requirements: 30% for partner assignments outside of primary location (primarily traveling within Switzerland or EU). 

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. 

Our company has had a presence in Switzerland since 1963. With a regional office and manufacturing/packaging facility, Lucerne is considered the center of operations. Approximately 1,000 people work collaboratively at the four Lucerne locations (Weystrasse, Citybay, Schachen and Kriens). A fifth location has been recently established in Zurich, aimed at accelerating the development and commercialization of many of our company’s medicines and vaccines, which supports our mission to save and improve lives around the world. The new location has a target date of 2021 for operational readiness. 

We are proud to be certified as a “Top Employer Switzerland” and “Top Employer Europe” showing the company’s commitment to our employees and the community around us.  

The Weystrasse building located in the city center of Luzern is headquarter to the local and regional departments of the Animal Health Organization in Switzerland. The site’s primary functions include Global Supply Chain Management, regional External Manufacturing and the European Finance Hub.  

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.

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:

Regular

Relocation:

Domestic/International

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

1

Requisition ID:R88542