Job Description

Our Large Molecule Technical Operations Unit is seeking a highly motivated individual to fill an open position to support sterile drug product manufacture within our External Manufacturing Network in Europe. This is an exciting opportunity to work with key strategic external partners, grow technical experience in sterile manufacturing, and work on high visibility network initiatives with direct access to senior management. Our team strives to provide technical excellence in our work and be strong partners, collaborators, and leaders within the large molecule lines of business at our company.

We are currently seeking a Sr Specialist Engineering for our team in Tribschen, Luzern.

Primary responsibilities for this position include, but are not limited to, the following:

Manages technical issues relating to the global external manufacturing of commercial Drug Product.

Takes accountability and ownership for Technical deliverables on their assigned projects.

Provide technical leadership within Technical Operations group for the management of sterile drug product.

Support technical transfers of new sterile drug product to our contract manufacturing sites.

Lead to resolve technical issues relating to a product line or major technical projects within Technical Operation.

Provide direct leadership for day-to-day technical activities for commercial drug product manufacturing –i.e., trouble shooting, process changes and improvements, new manufacturing technology implementation etc.

Independently act as the primary interface on technical issues between Technical Operations and third-party drug product manufacturers.

Provide technical leadership on Change Controls, investigations, and CAPAs and support of Health Authority Inspections.

Organize and lead ad hoc cross functional teams to manage investigations and implementation of CAPA and change controls.

Coordinates and manages risk assessments and develops solutions to complex issues that require a high degree of ingenuity, creativity and innovation. Requires understanding and application of principles, concepts, practices and standards that govern the manufacturing of sterile products.

This role includes approximately 25% travel.

Qualifications:

Education and Minimum Requirements:

Bachelor’s degree in engineering, biological/chemistry sciences or related discipline

A minimum of 7 years of relevant work experience in manufacturing, in the areas of process start up, routine manufacturing and/or technical transfer.

A minimum of 3 or more years of experience in sterile/ aseptic Drug Product processing including formulation and filling and technical transfers

Experience in Relationship Management

Required Skills and Experience:

Ability to work effectively across boundaries to build strong collaborative relation with other

internal teams, such as; Global Technical Operations, Sterile, External Services partner groups, Small and Large Molecule Sites and external partners.

Strong professional and interpersonal communication skills are also required.

Must be able to multi-task and work within tight deadlines.

Strong knowledge of Quality systems, Change Control Drug Product Manufacturing and Validation

Strong analytical problem-solving skills, root cause analysis and risk assessment/mitigation

Excellent command of English (both written and oral).

Preferred Experience and Skills:

Project management experience

Knowledge of worldwide regulatory requirements, experience supporting regulatory inspections

THE COMPANY

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 (Tribschenstrasse, Citybay, Schachen and Kriens). A fifth location has been stablished in 2021 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.

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.

Our Tribschenstrasse office, located in the city of Luzern has a rich diversity of employees at this location including Global Supply Chain Management, Regional External Manufacturing and one of our European Finance Hubs. The site also serves as our regional and local headquarters for our company’s Animal Health Division in Switzerland.

Current Employees apply HERE

Current Contingent Workers apply HERE

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:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

25%

Flexible Work Arrangements:

Hybrid

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

N/A

Job Posting End Date:

01/17/2025

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID:R322192