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Life Cycle Management Consultant Pharmaceuticals

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Amaris Consulting

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Location:
Belgium , Beerse

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Salary:

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Job Description:

We are seeking a detail-oriented Lifecycle Management Specialist Consultant with 4–6 years of experience in pharmaceutical manufacturing or operations to support Johnson & Johnson Innovative Medicine’s Primary Container team within the MSAT (Manufacturing Sciences & Technology) organization. The consultant will focus on managing change controls related to supplier change notifications for primary packaging materials used in large molecule drug product (DP) manufacturing. The role ensures continued compliance, quality, and process stability by evaluating supplier changes, leading technical assessments, and coordinating cross-functional activities across analytical, manufacturing, and quality functions.

Job Responsibility:

  • Change Control Management: Lead end-to-end change control processes for supplier-initiated changes to primary packaging materials
  • prepare and review all associated documentation (assessments, risk evaluations, implementation plans)
  • Specification Review: Evaluate supplier-provided specifications (e.g., glass vials, stoppers, caps) against internal quality and regulatory standards
  • Comparability Reporting: Author comprehensive comparability reports to assess impact on processability, product quality, and patient safety
  • Cross-Functional Coordination: Liaise with Analytical Development, Quality, Regulatory, Manufacturing, and Supply Chain teams to execute technical testing and validation activities linked to packaging changes
  • Data Analysis & Reporting: Utilize statistical tools to interpret data from process performance, fill-line trials, and stability studies
  • Compliance & Documentation: Ensure adherence to cGMP, ICH guidelines, and internal SOPs throughout the change lifecycle

Requirements:

  • Bachelor’s or Master’s degree in Pharmacy, Chemistry, Biology, Engineering, or a related life sciences field
  • 4–6 years of professional experience in pharmaceutical manufacturing, operations, MSAT, or technical support within a GMP environment
  • Proven knowledge of primary packaging materials (e.g., glass, elastomers) and their use in parenteral drug product filling processes (vials, syringes, cartridges)
  • Hands-on experience with change control systems, comparability protocols, and supplier change management
  • Strong understanding of cGMP regulations, quality systems, and lifecycle management principles
  • Fluency in English mandatory
  • Technical Skills & Software Proficiency: Comet (preferred) – for change and document management
  • Minitab – statistical analysis
  • SAP – ERP system navigation
  • Microsoft Office Suite – Advanced Excel, PowerPoint, Word
What we offer:
  • Rapid growth: Amaris has doubled its workforce in Belgium in two years, providing numerous growth opportunities for employees
  • Prestigious projects: Candidates will work with renowned clients in the pharmaceutical, biotechnology, and European institutions sectors on impactful missions
  • International environment: An agile and dynamic structure promotes intrapreneurship and meritocracy, with international exposure at the heart of Europe

Additional Information:

Job Posted:
February 14, 2026

Employment Type:
Fulltime
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