Gais, Appenzell Ausserrhoden, Schweiz/Suisse/Svizzera/Svizra
Onsite
Job Description
Located in the greater Lucerne area, the company`s Schachen Biotech facility is a state-of-the-art manufacturing and innovation hub supporting early-phase clinical supply for biologics and the introduction of new technologies into our development pipeline. The facility combines advanced manufacturing capabilities with a collaborative culture, enabling close partnership across teams, functions, and the global company network.
As part of the growing Biotech Process Engineering team, you will play a key role in advancing biologics manufacturing. In this senior, on-site position, you will lead the evaluation, implementation, and qualification of innovative equipment, processes, and next-generation technologies supporting development and clinical manufacturing. Working closely with local and global colleagues, you will help bring new technologies into GMP operations while driving safe, compliant, and efficient manufacturing processes.
This role offers a unique opportunity to influence the introduction of new manufacturing technologies, collaborate with experts across the global company network, and contribute directly to the future of biologics development and clinical manufacturing.
Responsibilities
Responsibilities and activities can be tailored to the successful candidate's experience, availability, and career aspirations and will primarily include:
Lead the evaluation, implementation, and qualification of new technologies, equipment, automation, and digital solutions to advance biologics manufacturing and accelerate technology innovation
Provide technical leadership for technology transfer, process improvement, and manufacturing projects, working closely with local and global teams to enable successful GMP batch and continuous manufacturing operations.
Act as a subject matter expert for process engineering activities, including equipment selection, process design, qualification strategies, risk assessments, and capital investment initiatives.
Drive the implementation of new manufacturing technologies and ways of working, helping to simplify operations, improve efficiency, and strengthen compliance across the site and network.
Provide technical leadership for Single-Use Technology (SUT) systems and standards, including strategy development, equipment and component selection, design reviews, change control, risk assessments, Extractables & Leachables (E&L) activities, and lifecycle support from design through qualification and operation.
Partner with Operations, Quality, Validation, Automation, and Process Development teams to solve complex technical challenges, support investigations, and deliver sustainable process improvements.
Author, review, and approve key engineering and GMP documentation, including user requirements, capital funding requests, change controls, risk assessments, SOPs, qualification protocols and reports, validation documentation, and technology lifecycle records.
Support knowledge management, share best practices, and mentor colleagues to strengthen technical capability and engineering excellence while ensuring activities are executed in accordance with GMP, quality, safety, and compliance requirements.
Required Experience and Skills
Minimum of 7 years of experience in the pharmaceutical or biotechnology industry.
Experience leading projects with cross-functional stakeholders.
Strong technical knowledge of biologics manufacturing, including upstream and downstream processing, process development, technology transfer, and process validation.
Strong understanding of cGMP requirements, EHS expectations, engineering documentation, and quality systems within a regulated environment.
Experience supporting investigations, CAPA, risk management, and continuous improvement initiatives.
Familiarity with automation and digital manufacturing technologies such as MES, DeltaV, SIPAT, PAT and similar systems is an advantage.
A collaborative and proactive working style, with the ability to work effectively both independently and within cross-functional teams.
Strong analytical and practical problem-solving skills, with the ability to challenge existing approaches and identify effective solutions.
Strong written and verbal communication skills in English (C1) and German (B1).
Required Skills:
Adaptability, Bioprocess Engineering, Deviation Management, Efficiency Improvements, Equipment Qualification, Good Manufacturing Practices (GMP), Manufacturing Processes, Problem Analysis, Process Improvements, Project Leadership, Strategic Thinking, Technical Leadership, Technical Problem-SolvingPreferred Skills:
Knowledge Transfer, Process ManufacturingCurrent 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:
RegularRelocation:
No relocationVISA Sponsorship:
NoTravel Requirements:
No Travel RequiredFlexible Work Arrangements:
Not ApplicableShift:
Not IndicatedValid Driving License:
NoHazardous Material(s):
N/AJob Posting End Date:
09/19/2026*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.
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