Job Description
Mission 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.
Key Responsibilities
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.
Profile 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
Why joining us?
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.
Amaris Consulting is proud to be an equal opportunity workplace. We are committed to promoting diversity within the workforce and creating an inclusive working environment. For this purpose, we welcome applications from all qualified candidates regardless of gender, sexual orientation, race, ethnicity, beliefs, age, marital status, disability, or other characteristics.
Who are we?
Amaris Consulting is an independent technology consulting firm providing guidance and solutions to businesses. With more than 1000 clients across the globe, we have been rolling out solutions in major projects for over a decade – this is made possible by an international team of 7,600 people spread across 5 continents and more than 60 countries. Our solutions focus on four different Business Lines: Information System & Digital, Telecom, Life Sciences and Engineering. We're focused on building and nurturing a top talent community where all our team members can achieve their full potential. Amaris is your steppingstone to cross rivers of change, meet challenges and achieve all your projects with success.
At Amaris, We Strive To Provide Our Candidates With The Best Possible Recruitment Experience. We Like To Get To Know Our Candidates, Challenge Them, And Be Able To Give Them Proper Feedback As Quickly As Possible. Here's What Our Recruitment Process Looks Like
Brief Call: Our process typically begins with a brief virtual/phone conversation to get to know you The objective? Learn about you, understand your motivations, and make sure we have the right job for you
Interviews (the average number of interviews is 3 - the number may vary depending on the level of seniority required for the position). During the interviews, you will meet people from our team: your line manager of course, but also other people related to your future role. We will talk in depth about you, your experience, and skills, but also about the position and what will be expected of you. Of course, you will also get to know Amaris: our culture, our roots, our teams, and your career opportunities
Case study: Depending on the position, we may ask you to take a test. This could be a role play, a technical assessment, a problem-solving scenario, etc.
As you know, every person is different and so is every role in a company. That is why we have to adapt accordingly, and the process may differ slightly at times. However, please know that we always put ourselves in the candidate's shoes to ensure they have the best possible experience.
We look forward to meeting you
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Consulting, Information Technology, and Sales
Industries
IT Services and IT Consulting