Vacancy expired!
Job Description
Responsibilities include:
Possibly remote. But looking for local candidates.
Provide technical leadership using engineering principles and drive forward projects varying from functional area projects focused on improving process equipment/utilities/facilities -to- large/complex capital projects to integrate new drug product manufacturing technologies into clinical/commercial facility. Leverage engineering expertise within the company and industry best practices, compliance with pertinent environmental health and safety practices, and aligning with evolving regulatory expectations and internal quality standards to implement new equipment and/or equipment/utility/facility modifications. Provide Commissioning & Qualification (C&Q) leadership to project teams to drive forward C&Q efforts for small projects (?$300K) e.g. equipment/utility/facility modification to large capital projects (?$3M) e.g. facility construction, new equipment integration into clinical/commercial facility. This includes ensuring effective communication flow between cross-functional teams (e.g. F&E, Manufacturing, Quality, Project controls, project management, EHSS) and functional management, leading the selection of contractors for C&Q execution, managing their training and performance, C&Q deliverables and schedule to meet project timelines, and ensuring compliance with Client safety, C&Q and Quality standards. Manage the portfolio of improvement/innovation projects within the F&E drug product engineering group using strategic approaches and resource prioritization. Be knowledgeable about compliance and regulatory aspects for equipment validation, operation and maintenance and support regulatory inspections and audits. Up to 10% domestic/international travel
6+ years' of relevant work experience with 3+ years' experience in Biopharmaceutical operations/manufacturing environmentExperience working in a regulated environment (e.g. cGMP, OSHA, EPA, etc.) and familiarity with GMP quality systems/processes such as change control, non-conformances, corrective and preventative actions, and qualifications/validationDirect knowledge of design and troubleshooting with GMP Biopharmaceutical Production facility equipment/systems such as continuous fill lines (washer, tunnel, isolator, cappers and lyophilization), filling, lyophilization, inspection, device assembly, cell culture reactors, chromatography, filtration as well as other equipment needed to support these processes such as autoclaves, clean in place (CIP) systems, washers, clean steam, water for injection, etc.Ability to analyze problems, develop and propose engineering solutions in a scientific manner using data-driven techniques and analyses (e.g., Root Cause Analysis (RCA), Statistical Process Control (SPC), Six Sigma, Predictive Maintenance, etc.)Experience applying engineering principles to the design and implementation of system modifications, introduction of new processes, and execution of capital projectsUnderstanding of the execution process of capital projects in a GMP Biopharmaceutical Production facility including procurement, construction, startup, and validationUnderstanding of safety requirements working in a GMP Biopharmaceutical Production facility.Independent, self-motivated, organized, able to multi-task in project environments, and skilled in communication, facilitation, and collaborationTeam player prepared to work in and embrace a team based culture that relies on collaboration for effective decision-makingStrong leadership, technical writing, and communication/presentation skillsWork schedule flexibility as required to support 24/7 operations, requiring occasional after-hours engineering coverageTop 3 Must Have Skill Sets:
Technical leadership, Commissioning & Qualification (C&Q) leadership , Knowledgeable in GMP Compliance
Qualifications
Basic QualificationsDoctorate degreeORMaster’s degree and 3 years of Engineering experienceORBachelor’s degree and 5 years of Engineering experienceORAssociate’s degree and 10 years of Engineering experienceORHigh school diploma / GED and 12 years of Engineering experience
Preferred QualificationsMaster’s degree in Chemical or Mechanical EngineeringAdditional Information
All your information will be kept confidential according to EEO guidelines.Vacancy expired!