- Supports the C&Q group in providing documented evidence that all equipment and utilities used within the organization are qualified and remain in a state of control to ensure processes and products comply with regulatory and business specifications.
- Is responsible for coordinating assigned qualification activities.
- Is responsible for the technical content of assigned equipment qualification files.
- Acts as a Technical Owner within the organization.
- Performs detailed assessments for assigned projects, changes, modifications, best practices, corrections, remediations, breakdowns, non-compliance issues, and investigations.
- Forwards requests to the C&Q Lead when appropriate.
- Participates in core team and planning meetings for assigned projects.
- Keeps work overview tools (e.g., Kanban boards) up to date.
- Requests support or information from the C&Q Lead when needed and escalates when required.
- Documents assessments and completed tasks in the applicable system(s).
- Communicates with involved departments regarding test planning, materials, and resources for assigned projects.
- Shares relevant project information with qualification engineers.
- Provides updates and support to qualification engineers as needed.
- Supports and, when necessary, guides qualification engineers in evaluating project issues and changes and assessing impact on qualification activities (e.g., protocol deviations, scope changes).
- Collaborates with qualification engineers to ensure qualification activities are performed qualitatively and within reasonable timelines.
- Reviews and approves qualification documents (e.g., URS, SRS, SIA, CARA, DQ, QP, IQ, OQ, discrepancies, PQ, QSO) in the electronic validation system.
- Collaborates with QA to obtain approval of qualification files.
- Acts as qualification engineer/technical writer when required.
- Reviews executed qualification tests documented by qualification engineers or other testers.
- Initiates and follows up on non-conformances and corrective actions in the applicable system(s) when required.
- Contributes to internal C&Q improvement initiatives.
- Assists in preparation for and support during internal and external inspections.
- Supports the maintenance of Validation Master Plans, including system inventories and qualification status.
- Assists in providing introductory qualification training.
- Acts as backup for other C&Q SMEs when required.
- Ensures proper handover of responsibilities before extended absences.
- Operates in compliance with GMP requirements.
- Maintains up-to-date knowledge of international regulations, guidelines, and industry practices related to system and process equipment qualification.
- Identifies procedural or documentation gaps and informs the C&Q Lead.
- Strives for high-quality qualification documentation.
- Identifies improvement opportunities and reports them appropriately.
- Completes all mandatory training within required timelines.
- Coaches qualification engineers.
- Provides feedback on quality of work delivered.
- Supports onboarding and training of new team members when requested.
- Minimum 5 years of relevant pharmaceutical experience in a GMP-regulated environment.
- Technical knowledge of aseptic/sterile equipment and processes required.
- Technical or scientific educational background preferred.
- Local language proficiency is a plus.
- Experience with electronic validation systems is a plus.
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C&Q SME (Commissioning & Qualification Subject Matter Expert) · Objectives and Responsibilities · The function holder: · Supports the C&Q group in providing documented evidence that all equipment and utilities used within the organization are qualified and remain in a state of co ...
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· General information · Publication date · /01/2026 · Category · OPERATIONS - ENGINEERING/PRODUCTION · Job title · C&Q SME Engineer · Contract · Permanent contract · Job description · Over de rol · Als Teamlead C&Q (Commissioning & Qualification) – SME (Subject matter expert) b ...
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This job is with Johnson & Johnson, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly. · At Johnson & Johnson, we believe health is everything. Our strength in healthcare in ...
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c&q sme - Beerse - Panda International
Beschrijving
C&Q SME (Commissioning & Qualification Subject Matter Expert)
Objectives and Responsibilities
The function holder:
Main Tasks / Additional Tasks / Authority
Technical and Function-Specific Tasks and Responsibilities
Quality and Compliance Responsibilities
Staff Responsibilities
Qualifications & Experience
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c&q sme
Alleen voor geregistreerde leden Beerse
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c&q sme
Alleen voor geregistreerde leden Beerse, Flemish Region
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c&q sme
Alleen voor geregistreerde leden Antwerp
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c&q sme
Alleen voor geregistreerde leden Antwerp, Flemish Region
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c&q sme
Alleen voor geregistreerde leden Antwerp
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SME C&Q Engineer
Alleen voor geregistreerde leden Beerse
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C&Q SME Engineer
Alleen voor geregistreerde leden Beerse - Europe, Belgium, Flanders, Antwerp
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SME C&Q Engineer
Alleen voor geregistreerde leden Beerse, Flemish Region
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c&q sme
Alleen voor geregistreerde leden Antwerp Metropolitan Area
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c&q sme
Alleen voor geregistreerde leden Antwerp
-
Commissioning & Qualification (C&Q) SME
Alleen voor geregistreerde leden Antwerp
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Commissioning & Qualification (C&Q) SME
Alleen voor geregistreerde leden Antwerp, Flemish Region
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C&Q lead
Alleen voor geregistreerde leden Geel, Antwerp, Belgium
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C&Q engineer
Voltijd Alleen voor geregistreerde leden Geel
-
C&Q lead
Alleen voor geregistreerde leden Geel, Flemish Region
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C&Q lead
Alleen voor geregistreerde leden Geel, Flemish Region
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C&Q engineer
Alleen voor geregistreerde leden Geel
-
C&Q lead
Voltijd Alleen voor geregistreerde leden Geel
-
C&Q engineer
Alleen voor geregistreerde leden Geel, Flemish Region
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C&Q lead
Alleen voor geregistreerde leden Geel
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C&Q engineer
Alleen voor geregistreerde leden Geel, Antwerp, Belgium