Process Engineer I Workflow Development for Biologics-SAP-3228

ExecuPharm is the North American clinical operations business within Parexel FSP. We provide biopharmaceutical companies with qualified and talented professionals to accelerate the development and delivery of new therapies.

For results-driven and caring individuals who want to make a meaningful difference in the world, Parexel is the CRO trusted by life sciences companies to innovate keeping patients at the center of everything we do, and where an inclusive global community helps you be your best, transforming any career into a life-changing achievement.

Role is for 3Q2021-3Q2022 (12 mos maximum)

Qualifications Bachelor’s Degree in business administration, Science, Engineering, or another technical field with a minimum of 3 years of relevant experience is required. Minimum 1 year experience in SAP Required Skills and Experience Demonstrated knowledge of Lean with experience in developing process workflows (e.g., kaizen, value stream mapping, etc.) GMP experience: cGMP manufacturing environments, or related experience Must be able to gown to meet cGMP or safety requirements Skills: Demonstrated interpersonal skills including flexibility, collaboration, and inclusion skills Demonstrated critical thinking skills and problem solving Strong written and verbal communication skills Strong organizational and planning skills Ability to work independently and in a team environment with multiple project teams Desired Skills and Experience Experience in relevant manufacturing or processing (aseptic/sterile, bulk, solid oral dosage, packaging, etc.) Experience in heavily regulated industry (e.g., Federal Drug Administration (FDA), military, nuclear and petroleum / chemical) Responsibilities Partnering with Biologics Support Operations (BSO) staff within Clinical Manufacturing to learn current workflows and business systems, determine and optimize new and innovative workflows, and use this knowledge to help construct the new SAP system. Fully engage with the SAP team, Receiving/Shipping, Warehousing, Weighing and Dispensing, and Media Buffer Preparation teams, as they collaborate, design, and implement SAP into the work area. Demonstrated excellent understanding of the regulatory guidelines governing GMP manufacture. Escalate concerns to management when necessary. Under the direction of the area supervisor, learn the various manufacturing roles. Read and understand SOP and GMP guidelines, stay compliant in all safety and GMP trainings, attend working meetings and breakout sessions. Ensure that project objectives are achieved while reliably supplying quality clinical products under the guidance of Company, Regulatory Agency, and State and Local code requirements Promote the behaviors and principles that drive continuous improvement and safety Ensure work is documented in compliance with the ALCOA principles of data integrity, cGMPs, GLPs, and departmental procedures Collaborates with key stakeholders and keeps Management informed of key proposals, milestones, and decisions QualificationsRole is for 3Q2021-3Q2022 (12 mos maximum)

Qualifications Bachelor’s Degree in business administration, Science, Engineering, or another technical field with a minimum of 3 years of relevant experience is required. Minimum 1 year experience in SAP Required Skills and Experience Demonstrated knowledge of Lean with experience in developing process workflows (e.g., kaizen, value stream mapping, etc.) GMP experience: cGMP manufacturing environments, or related experience Must be able to gown to meet cGMP or safety requirements Skills: Demonstrated interpersonal skills including flexibility, collaboration, and inclusion skills Demonstrated critical thinking skills and problem solving Strong written and verbal communication skills Strong organizational and planning skills Ability to work independently and in a team environment with multiple project teams Desired Skills and Experience Experience in relevant manufacturing or processing (aseptic/sterile, bulk, solid oral dosage, packaging, etc.) Experience in heavily regulated industry (e.g., Federal Drug Administration (FDA), military, nuclear and petroleum / chemical) Responsibilities Partnering with Biologics Support Operations (BSO) staff within Clinical Manufacturing to learn current workflows and business systems, determine and optimize new and innovative workflows, and use this knowledge to help construct the new SAP system. Fully engage with the SAP team, Receiving/Shipping, Warehousing, Weighing and Dispensing, and Media Buffer Preparation teams, as they collaborate, design, and implement SAP into the work area. Demonstrated excellent understanding of the regulatory guidelines governing GMP manufacture. Escalate concerns to management when necessary. Under the direction of the area supervisor, learn the various manufacturing roles. Read and understand SOP and GMP guidelines, stay compliant in all safety and GMP trainings, attend working meetings and breakout sessions. Ensure that project objectives are achieved while reliably supplying quality clinical products under the guidance of Company, Regulatory Agency, and State and Local code requirements Promote the behaviors and principles that drive continuous improvement and safety Ensure work is documented in compliance with the ALCOA principles of data integrity, cGMPs, GLPs, and departmental procedures Collaborates with key stakeholders and keeps Management informed of key proposals, milestones, and decisions EEO DisclaimerParexel is an equal opportunity employer.  Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.