Technical Operations Engineer

Qualifications:

Education: Bachelors in Engineering, Science, or appropriate discipline. Required experience/skills: At least 6 years of hands on pharmaceutical manufacturing experience in the areas of process start up and/or demonstrated experience in pharmacuetical manufacturing. In-depth understanding and proven expertise in application of quality systems, especially technical subsystems related to process and equipment qualification, change control, deviation management and cleaning qualification; Advanced understanding of the relevant scientific/ technical concepts to execute routine and increasingly complex tasks; advanced working knowledge in the relevant scientific /technical techniques and is able to apply those techniques to routine and increasingly complex tasks; Proficient in the areas of analytical skills, decision-making, organizational, project planning and management skills; Strong communication skills for technical investigations (oral or written). Preferred Experience/Skills: Expertise in MPS including Lean Six Sigma green belt level certification, with black belt preferred; Statistical data analysis with Minitab; Demonstrated interaction with external partners.

Responsibilities:

Senior Specialist, Pharm Tech Ops- External Manufacturing The Senior Specialist, Pharm Tech Ops will be responsible to act as the technical interface between our Company and assigned strategic External Partners (Contract Manufacturing Organizations) in the Americas region. The role will report to Director, Pharmaceutical Technical Operations – External Manufacturing Tech Strategy and Execution and will be a member of the External Manufacturing Technology group within the Pharm Technical Operations – Drug Product platform. This role will provide technical leadership and oversight in the areas of technology transfer, process qualification and support, deviation resolution, root cause analysis, change control, process optimization, project management, technical capability and due diligence assessments for assigned partners. As such, this role is the technical point of contact for the CMO and collaborates with other core functions (Quality, Operations, Supply Chain) and also other specialty Centers of Excellence (COE) in the Science & Technology organization where needed. The scope of work includes: • Technology transfers, Investigations, Process Improvements, and Change Control; • Technical support and resolution of Quality issues such as Deviations and Customer Complaints; • Functioning independently and providing coordination, communication, and oversight on all technical matters pertaining to the assigned external partners; • Responsibility for the technical aspects of Fact Finding around quality and supply investigations; • Project accountability to execute Technology Transfer and on-going process support; support and highlighting the need for the leveraging of shared resources from the Science and Technology organization; • Together with the Focused Factory Team (Ops, Quality, Tech), establishing a calibrated technical oversight approach based on the capabilities and technical competence of an external partner; • Together with the Focused FactoryTeam, establishing clear expectations, measures and periodic monitoring of operational and quality performance associated with the assigned external partners; • Providing technical expert consultation and review on commercial agreements; • Participating in Technical due diligence assessments • Assuring site technical readiness for all new product introductions or transfers; • Participating in periodic Business and Relationship Review Meetings (as appropriate) with the assigned external partner

Comments/Special Instructions

Fully Remote

Heavily Preferred:

Packaging operations experience

Ability to speak Portuguese

Change control system experience