Job description
Your Responsibilities
* Project Management
o Drive completion of detailed design in line with defined deliverables, project scope, and GMP requirements.
o Ensure design intent is maintained through all phases (basic design → detailed design → execution).
o Review and approve design documents, drawings, and equipment specifications to confirm technical quality and constructability.
o Monitor and control project scope, schedule, cost, and risk, including change management (TCRs, CRs).
o Facilitate design coordination between EPCM, internal engineering teams, quality assurance and operations.
o Support procurement activities (long-lead equipment) to ensure alignment with design and construction sequencing.
* Compliance & Documentation
o Ensure adherence to GMP regulations, company policies, and industry standards throughout the project lifecycle.
o Collaborate with quality assurance teams to ensure project deliverables meet all regulatory requirements.
o Maintain comprehensive project documentation, including risk assessments, design reviews, and performance qualification (PQ) records.
* Resource Management
o Manage project resources, including internal staff and external contractors, to ensure timely and efficient project execution.
o Develop and manage the project budget, tracking expenditures and addressing variances proactively.
* Performance Qualification (PQ)
o Oversee and coordinate performance qualification (PQ) activities, ensuring the system meets intended operational and regulatory requirements.
o Collaborate with production staff during PQ to validate operational improvements and mechanical adaptations.
* Education and Qualifications
o Bachelor's degree in Engineering (Mechanical, Process, Chemical, or related field). Master's degree is a plus.
* Experience
o Minimum of 5-7 years of experience in project management within a biopharmaceutical or regulated manufacturing environment.
o Proven track record of managing GMP-compliant engineering projects from design to qualification.
o Experience working with EPCM contractors and cross-functional teams, including operations and quality assurance.
About the customer
For one of leading pharmaceutical company, we are seeking an experienced Senior Engineering Project Manager to ensure the flawless transition from detailed design to construction and qualification of mechanical adaptations within an existing GMP commercial mammalian production line. We require the capabilities of an engineering project manager to drive design completion to defined deliverables.
Requirements
Your Profile
Experiences
* Strong project management skills, including budgeting, scheduling, and risk management.
* Excellent knowledge of GMP regulations and change management protocols (TCRs and CRs).
* Exceptional communication and stakeholder management skills.
* Proficiency in project management tools and software (e.g., MS Project, Primavera).
* Strong problem-solving and decision-making capabilities.
* English required to communicate with all stakeholders; German is strongly preferred.
* Certifications (Preferred):
* PMP (Project Management Professional) certification.
* Lean Six Sigma or other operational excellence certifications are a plus.
Online Application (2 minutes)
If you are ready to make an impact today, we are looking forward to your online application with your latest CV and your availability. If your profile is shortlisted, our consultant will contact you for a first call to discuss the details.
#J-18808-Ljbffr