Life Cycle Management Consultant Pharmaceuticals Job at Amaris Consulting (Beerse)

Life Cycle Management Consultant Pharmaceuticals

Amaris Consulting

Location:
Belgium , Beerse

Category:
-

Contract Type:
Not provided

Salary:

Not provided

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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