C&Q Compliance SME
Job
Overview
Ireland, , Cork
- Engineering and Project Management
- Contract
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Job Title: GE C&Q Capital Team Compliance SME
Location: Remote - Europe
Type: Contract
Duration: 6 Months+
TRS are looking for a C&Q Compliance Specialist to work for a global Pharmaceutical Company based in Ireland. This is fully remote role supporting their site operations in Europe. This is an initial 6 month contract very likely to be extended.
Job Description
In this role, this individual will play a key role as a business partner with other functions - Engineering, Maintenance, Operations, and Quality - to support the Global Engineering Capital C&Q program and Engineering Compliance requirements
This position focusses on the C&Q elements of GE Capital Program alignment. The role is focused on design and management of the C&Q lifecycle as directed by the industry guidance. The primary objective of the role is to work collaboratively with site functions to benchmark alignment of the GE Capital Lifecycle to ensure efficient Project Execution strategies are replicated across the network and that the C&Q guidance / toolkit is current and effective. The role also focusses on the design of the GEP/GMP toolkit to ensure alignment with all Capital functions (Design, EHS, Construction & Project Controls)
Responsibilities
- Provide technical engineering input to the design of the GE C&Q Capital Lifecycle
- Technical SME for Quality Revolution, Equipment, Facility & Utility Qualification workstream (deploy, adoption and value realization phases)
- Provide technical engineering input to design of a Global Vendor Assessment program to allow leveraging of completed Vendor Assessments across the network
- Provide technical engineering input to design of an integrated Equipment and Automation C&Q program to align with ISPE Baseline Guide, Commissioning and Qualification, Vol 5, 2nd edition
- Collaborate with matrix organization to optimize GE C&Q Equipment Qualification /Regulatory implementation.
- Effectively interact with leadership and partner with Engineering, Maintenance, Operations, and Quality stakeholders to establish C&Q lifecycle priorities
- Support Global Engineering standardization for Mechanical Completion definition for projects within the assigned areas.
- Assist in ensuring capital project investments use the best C&Q technology, have the best outcomes for business, and align with contemporary C&Q standards and regulatory requirements.
- Maintain a working familiarity with current industry best practices and cGMP requirements. Maintain technical skills in the latest techniques for project management and pharmaceutical processing technology.
- Coordinate resources to ensure completion of training of all functions that input to the GE C&Q program deliverables
- GE EDES SME for full C&Q paperless adoption in support of sustainability objectives
- Regulatory & GMP/GDP Expertise: Demonstrates strong working knowledge of global GMP/GDP regulations and regulatory authority expectations. Interprets regulatory requirements and translates them into practical, compliant engineering and operational controls.
Quality Systems & Process Compliance: Applies deep understanding of Quality Management Systems (QMS), including deviation management, CAPA, change control, and risk management. Ensures engineering processes and procedures are compliant, standardized, and effectively implemented. - Risk-Based Decision Making: Identifies, assesses, and manages compliance risks using structured, risk-based methodologies. Proactively mitigates risk and supports sound, defensible decisions aligned with regulatory and business expectations.
- Audit & Inspection Readiness: Supports internal and external audits and regulatory inspections. Confidently explains engineering systems, processes, and compliance rationales, and contributes to effective and sustainable responses to observations. If required, represent GE Engineering for support for internal and regulatory audits associated with key Capital projects, and all compliance related activities for the assigned capital project portfolio.
- Technical & Engineering Authority: Applies strong engineering fundamentals to provide credible technical oversight of asset design, qualification, operation, and lifecycle management. Ensures systems are fit for intended use and compliant throughout their lifecycle.
- Change Management & Continuous Improvement: Evaluates compliance impacts of engineering and process changes. Applies continuous improvement principles to strengthen compliance maturity while enabling innovation and operational efficiency.
- Data Integrity & Digital Enablement: Demonstrates strong understanding of data integrity principles (ALCOA+). Supports and champions digital tools and systems that enhance compliance, traceability, and data reliability.
- Stakeholder Engagement & Influence: Effectively collaborates with Engineering, Quality, Operations, and Leadership stakeholders. Influences decisions through clear communication, technical credibility, and risk-based recommendations.
- Accountability & Judgement: Exercises sound professional judgement and takes ownership for compliance decisions and outcomes. Escalates risks appropriately and acts decisively to protect patient safety, product quality, and regulatory compliance.
- Compliance Culture & Leadership: Leads by example in promoting a strong compliance and quality culture. Coaches others on compliant behaviours and reinforces right-first-time execution of engineering and quality practices.
Required Experience
- Minimum of a Bachelor of Science (BS) Degree in Engineering or Related Discipline from a fully accredited institution. (preferred but not mandatory for application)
- Minimum of 9 years of engineering and/or project management experience.
- Communication Skills: Excellent oral and written communication skills, including presentations.
- Experienced in a pharmaceutical / FDA-regulated manufacturing environment. A solid working knowledge of cGMP and facility/equipment validation requirements.
- Demonstrated commitment to values-based leadership and achieving objectives in a manner that is supportive of the Pfizer Values and Leader Behaviors.
- Ability to write clearly, concisely, and persuasively in a professional environment.
- Ability to prepare and present clear and concise Power Point Presentations
- Demonstrated ability to build and maintain highly effective teams.
- Demonstrated ability to interact effectively with all levels of the organization.
PREFERRED QUALIFICATIONS
- Certificates, Licenses or Registrations: PMP Certification by PMI
PHYSICAL/MENTAL REQUIREMENTS
- Ability to perform complex data analysis and develop/manage detailed implementation plans.
- Ability to track performance against approved plans and react appropriately to unexpected outcomes.
- Ability to present plans and status updates to leadership and a broad range of stakeholders across the organization
If interested in this opportunity, please feel free to contact Conor Dolan at conor.dolan@trsstaffing.com
We are an equal opportunity employer. All qualified individuals will receive consideration for employment without regard to race; color; age; sex; sexual orientation; gender identity; religion; national origin; disability; veteran status; genetic information; or any other criteria protected by governing law.
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