CoE Equipment Reliability (m/f/d)

Job Description

Our Company`s Schachen site serves as a magnetic force that attracts, recognizes, and integrates people from diverse backgrounds and perspectives. Employees feel not only that they belong at Schachen, but also that the site belongs to them and is shaped by them.

The Biotech facility at Schachen is a state-of-the-art facility that enables and advances our best work. By integrating leading-edge technology with a dynamic, activity-based workspace, the facility supports seamless connection and collaboration within and across teams and functions. Schachen Biotech provides biologics drug substance manufacturing for early-phase clinical supply and the implementation of technology innovations into the pipeline.

The Center of Excellence Equipment Reliability Associate Director at Schachen is accountable for the successful introduction, ongoing maintenance, and continuous improvement of BPR&D’s equipment calibration and maintenance strategy. The CoE Equipment Reliability AD leads strategic planning and execution to meet utilization targets, optimize facility capacity, and ensure compliance with industry standards and regulatory requirements. This role champions a culture of self-direction, empowerment, and accountability while providing critical support to a diverse, cross-functional team. As the site’s expert in risk management, service provider coordination, and quality system ownership, this role drives operational excellence and reliability across all calibration and maintenance activities.

The primary activities include but are not limited to the following activities:

Cross-Functional Leadership / Governance

• Develops the organization and culture (including values and behaviors such as empowerment, diversity and inclusion, accountability, trust, open communication)

• Stay up to date with changes in regulatory standards and internal policies and ensure that the organization is prepared to meet these changes.

• Builds and sustains strong networks in and outside the organization.

• Develop and implement engineering strategies and plans to support the company's objectives, including facility upgrades, new equipment installations, and process improvements

• Lead or contribute to cross-functional working groups focused on facility readiness, compliance, and remediation.

• Prepare presentations, dashboards, and status reporting for leadership and governance forums.

• Provide technical leadership to junior staff, project teams, and contractors where required.

• Support harmonization of SOPs, work instructions, and governance models for facility compliance processes.

• Ability to take over special assignments and projects as needed, demonstrating flexibility, ownership, and a proactive approach to addressing evolving business priorities.

• Deputy to the T&E CoE Facility Compliance , supporting compliance across cleanrooms, utilities, HVAC, and infrastructure, as well as qualification oversight, contamination control strategy, deviations/CAPAs, shutdown coordination, and remediation of unplanned facility events.

Technical:

• Own and oversee the compliance strategy for all calibration and maintenance activities, ensuring adherence to applicable regulations, corporate policies, and industry standards; lead periodic reviews, audits, gap analyses, and corrective action plans within Biotech Operations

• Drive simplification, standardization and proactive problem mitigation in the Equipment Reliability space.

• Owns the outsourcing strategy and coordinated scientific support with for calibration and maintenance of the Biotech Operations laboratory and manufacturing equipment.

• Define and implement the equipment storage strategy and lead the spare parts strategy for BPR&D Schachen, including parts criticality assessment, stocking levels, supplier qualification, and lead-time management, while establishing clear equipment ownership accountability to support compliant, efficient, and reliable asset lifecycle management.

• Drive operational excellence for BPR&D Schachen department by defining and implementing continuous improvement programs (Lean/Six Sigma), performance KPIs and dashboards (including qualification timelines and change-management process metrics), preventative maintenance optimization and cross-functional process standardization.

• Support site readiness for all regulatory activities by serving as the Equipment Reliability SME for regulators and internal audits, and by preparing technical input, risk assessments, and compliance evidence.

• Serving as the Center of Excellence for Risk Assessments, including Quality Risk Management (QRM), Environmental Health and Safety (EHS) Risk Assessments, and Contamination Control Assessments.

• Developing and managing Service Level Agreements (SLAs) with external service providers to ensure optimal performance and reliability.

• Partner closely with the Process Engineering, TLE and Manufacturing Operations function to develop a network of engineers on best practice Asset Care, preventative and predictive maintenance to drive efficiency and cost improvement.

Required Education, Experience and Skills:

• Bachelor’s degree (B.S.) or equivalent in biology, chemical engineering, or a related discipline with at least 10 years or master’s degree (M.S.) with at least 8 years previous experience in a relevant position in GMP manufacturing in the pharmaceutical or biotech industry

• Ability to interpret and apply PIC/S guidance, especially in areas related to equipment qualification, calibration control, and data integrity

• Deep knowledge of GxP, cGMP, and global regulatory expectations, including FDA, Swissmedic, PIC/S and Iso standards

• Ability to work independently and manage multiple projects simultaneously

• Proactive mindset with a commitment to continuous improvement

• Strong understanding of validation principles and regulatory requirements and methodologies

• Excellent analytical skills, and detail orientate

• Exceptional knowledge of all pharmaceuticals rules and standards

• Working knowledge of cGMP regulations

• Demonstrated supervisory and leadership skills

• Excellent oral / written communication skills in English (C1)

Preferred Experience and Skills:

• Proficiency with Computerized Maintenance Management Systems (CMMS) and Enterprise Resource Planning (ERP) platforms (e.g., SAP, Hexagon)

• Significant experience in pharmaceutical, biotech, or regulated manufacturing environments.

• Strong background in Annex 1, cleanroom compliance, contamination control, utilities, HVAC, and facility qualification.

• Experience in commissioning, qualification, validation, and GMP QA oversight.

• Knowledge of deviation management, CAPA, risk assessment, change control, and inspection readiness.

• Ability to act as a strong cross-functional coordinator and technical SME in matrix organizations.

• Advanced understanding of equipment lifecycle management, including commissioning, qualification, operation, maintenance, and decommissioning

• Strong knowledge of risk-based maintenance, criticality assessments, and compliance-driven maintenance programs

Required Skills:

Adaptability, Adaptability, Chemical Engineering, Customer-Focused, Data-Driven Decision Making, Drug Product Development, EHS Compliance, Enterprise Resource Management (ERP), Enterprise Resource Planning (ERP), Environmental Health And Safety, Estimation and Planning, HVAC Systems, Manufacturing Quality Control, Operational Excellence, Periodic Reviews, Pharmaceutical Process Development, Process Control Automation, Process Engineering, Process Optimization, Process Standardization, Product Formulation, Risk Assessments, Risk Management, Safety Compliance, Strategic Thinking {+ 2 more}

Preferred Skills:

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:

10%

Flexible Work Arrangements:

Not Applicable

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

N/A

Job Posting End Date:

06/26/2026

*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.