CoE Facility Compliance (m/f/d)

Job Description

Our 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 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 T&E CoE Facility Compliance function serves as the Annex 1 SME and facility point of contact for GMP-regulated facility systems, driving compliance across cleanrooms, utilities, HVAC, and infrastructure. It leads facility-related qualification oversight, supports the contamination control strategy, manages deviations/CAPAs, and coordinates cross-functionally to maintain inspection readiness and operational excellence. It also drives shutdown coordination, responds to unplanned facility interruptions, leads remediation of unplanned facility events, and resolves issues to improve facility utilization.

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.

• Drive simplification, standardization, and proactive problem mitigation in the facility through 5S, optimization, and continuous improvement initiatives.

• 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 Equipment Reliability function, supporting the calibration and maintenance strategy, utilization and capacity optimization, compliance, and cross-functional coordination.

Annex 1 SME Responsibilities

• Serve as a subject matter expert for EU GMP Annex 1 compliance, with focus on low bioburden manufacturing, contamination control strategy, and cleanroom/utility requirements.

• Provide guidance on Annex 1 impacts to facilities, utilities, HVAC, cleanrooms, environmental monitoring, and equipment qualification.

• Assess compliance gaps against Annex 1 and drive remediation plans, CAPAs, and change control actions.

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

• Partner with QA and Engineering to ensure Annex 1 expectations are embedded into project and operational standards.

Facility Point of Contact Responsibilities

• Act as the primary Facility POC for GMP-related topics impacting building systems, utilities, HVAC, BMS, cleanrooms, and infrastructure.

• Serve as a Business Unit partner to the Facility Management team, with oversight and ownership for the decision-making, coordination, and closeout of all GMP and building infrastructure activities to ensure GMP compliance and operational continuity.

• Coordinate between BPR&D, QA, GWES, Supply Chain, and vendors to resolve facility and compliance issues.

• Support day-to-day oversight of facility systems to maintain operational readiness and a state of control.

• Drive and lead facility-related walkdowns to promote housekeeping, identify opportunities for improvement, and support a culture of continuous improvement.

• Manage or support escalations related to deviations, technical issues, maintenance impacts, and system changes affecting GMP status.

• Ensure effective communication and alignment of facility priorities, project milestones, and compliance deliverables across stakeholders.

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

• Strong knowledge of EU GMP Annex 1, contamination control strategy, and GMP facility requirements

• Experience with biotech/pharmaceutical regulated facilities, including cleanrooms, utilities, HVAC, BMS, and infrastructure

• Solid understanding of facility qualification, validation, and maintenance/calibration governance

• 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

• Working knowledge of cGMP regulations

• Demonstrated supervisory and leadership skills

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

Preferred Experience and Skills:

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

• Experience in biologics or early-phase clinical supply manufacturing

• Knowledge of cleanroom design, environmental monitoring, and aseptic/low bioburden operations

• 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.

• Familiarity with systems such as BMS, DeltaV, EMS, CMMS, SAP, TrackWise, Kneat, or similar platforms.

• Familiarity with facility lifecycle management, including upgrades, new equipment installation, and infrastructure changes

Required Skills:

Adaptability, Adaptability, Chemical Engineering, Cleanroom Design, Contamination Control, Customer-Focused, Data-Driven Decision Making, Drug Product Development, Environmental Monitoring, Estimation and Planning, Facility Management, GMP Compliance, HVAC Systems, Inspection Readiness, Manufacturing Environments, Manufacturing Quality Control, Pharmaceutical Process Development, Process Control Automation, Process Optimization, Product Formulation, Risk Assessments, Safety Compliance, Strategic Thinking, Technical Issues, Technical Mentoring {+ 2 more}

Preferred Skills:

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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:

06/25/2026

*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.