|28 days ago
In collaboration with a major biopharma client in Amsterdam, we are urgently seeking a dynamic and highly experienced Senior Engineer to play a pivotal role in leading and executing critical projects aimed at improving production process. You will oversee complex projects from initial conception through to completion, coordinating with multiple departments, and ensuring all technical and quality aspects are addressed effectively.
The ideal candidate will not only continue the momentum of ongoing projects but will also assume full ownership, steering these initiatives to successful and timely completion.
Bottom Plate Damage Assessment and Remediation:
Develop and execute protocol to assess the state of the bottom plate post manual polishing.
Lead the SWAB TOB execution on the bottom plate, report findings, and complete and close relevant action items and events.
IGJ Remediation Inova Filling Line Compliance Upgrade:
Manage the project charter, detail planning, and organization of maintenance shutdown activities.
Coordinate with core team members and act as the contact for slot requests.
Oversee Quality Process Plan (QPP) development and approval.
Installation and Optimization of Particle Counters:
Conduct grid studies, risk assessments, and finalize the location for particle counter installation.
Manage the implementation process, including the creation of Method of Change (MOC), obtaining quotes, and executing qualification protocols.
New LAF Installation Above the Capping Bowl:
Supervise the mock-up, quotation, and installation of a new Laminar Air Flow (LAF) system.
Develop and execute Installation, Operational, and Performance Qualification (IOQ/PQ) protocols.
Stopper Height Sensor Project:
Lead the stopper height acceptance criteria study and camera study to assess the current state of machinery.
Oversee the improvement of stoppering process and sensor installation, including URS drafting, protocol execution, and MOC completion.
Direct and collaborate with a multidisciplinary team, including CQV Engineers, Quality Control, Validation Experts, Production, SMEs in particle counters and smoke studies, and Quality Assurance.
Master’s degree in Engineering, Pharmaceutical Sciences, or related field.
5 years minimum and recent proven experience in pharmaceutical manufacturing, specifically in process upgrades and equipment installation.
Strong knowledge of cGMP procedures, regulatory requirements (EMA/FDA & IGJ), and risk management tools (HAZOP/PFMEA).
Experience in project management, including planning, execution, and team coordination.
Excellent communication and interpersonal skills to interact effectively with all levels of the organization.
Highly preferred filling line specialist
Strong analytical and problem-solving skills.
Proven ability to manage multiple projects simultaneously and meet deadlines.
Detail-oriented with a focus on quality and compliance.
Proficient in project management tools and software (e.g., MS Project, MS Office).
Respond with your CV by email firstname.lastname@example.org or call Vladislav Niesov on +31 (0)20 20 44 502