Company Overview:
My client is a leading Pharma and Medical Device company that develops combination products, boasting a global portfolio of best-in-class brand-name products, as well as global key brands; generics, including branded and complex generics; and other offerings across a wide range of therapeutic areas.
Job Description:
The Principal Equipment Engineer will be an SME in the management and delivery of equipment, inclusive of specification, procurement, delivery, qualification, and project management. This individual will lead equipment delivery projects with suppliers, manage budgets, and own specifications through to qualification. They will collaborate with cross-organizational teams to achieve success.
Responsibilities:
Develop engineering systems strategies for program delivery
Pilot and scale up subassembly, final assembly, labelling, packaging, transport, and auxiliary systems
Establish and maintain timelines against organizational requirements and identify external partners/OEMs to meet internal needs
Lead engineering systems in cross-departmental teams and manage engineering system objectives in line with program delivery
Support the device program team through communication, plan management, technical review, and execution, budgetary management, risk assessment, etc.
Accountable for process specification, development, and realization from product concept to commercialization
Identification and management of risk through established practices and RAID for engineering systems and program delivery
Lead development of bespoke manufacturing processes, manufacturing specifications, equipment, manual or benchtop systems, semi and fully automated equipment meeting product performance and quality requirements
Continuous focus on capacity scale up, while managing cost requirements
Responsible for site integration, establishing training needs, transport, site specification, commissioning, and qualification activities, product quality, ensuring process performance metrics, development batch record, process, and product.
Requirements:
Degree in Science/Engineering with 7+ years experience in pharmaceutical and/or medical device development or similar role
Strong project management experience is highly preferred
Enthusiastic, conscientious, highly driven, and motivated person
Good communication skills and commitment to teamwork are essential
Ability to write technical reports and produce high-quality documentation within a regulatory-controlled GMP environment
Benefits:
Competitive salary
Bonus
Pension
Full family healthcare
Hybrid working