Quality Project Engineer – Sartorius Stedim Biotech – Yauco, PR

Main Responsibilities & Tasks:

• Lead risk assessment for quality issues/deviations/claims in assigned project
• Ensure continuity between functional analysis, FMEAs, list of critical and special product and process characteristics, control plan, work and inspection instructions in assigned project
• Supervise, define scope and approve process and measurement system capability studies (internal and at vendors)
• Create Control Plan, maintain until launch and handover to Plant Quality
• Create inspection instructions and train operators/inspectors
• Create specifications for vendors, for in-process control, for finished product inspection
• Participate actively to definition, redaction and approve qualification and validation protocols – CSV, Product, Process, Equipment – ensure data driven validations and qualifications
• Participate actively or lead optimizations to solve qualification/validation non conformities
• Specify, monitor manufacturing and approve gauges and checking equipment with CI&T engineer
• Lead, optimize and release measurement system analysis for attribute inspections and checking equipment
• Identify, facilitate and track continuous improvement initiatives to reduce quality issues – Identify and carry out statistical analysis and experiments
• Implement statistical process control in Production where applicable according to control plan
• Lead and facilitate Product and Process FMEAs in assigned projects
• Capitalize and transversalize best practices (product, process, system) and knowledge from projects and from local Plant to other FMT sites
• Support local Plant Quality on solving of Quality issues (customer claims, vendor claims, internal scrap…)
• Support/lead and track Product Changes for assigned project
• Approve working instructions, ensure adaptability/efficiency of instructions for operators
• Lead and facilitate workshops/groups for problem solving

Qualifications & Skills:

• Bachelor degree in Engineering or biotechnology
• Approx. 3 years’ experience in production or in engineering center – industries targeted biotech, automotive, pharma.
• 6 Sigma Green Belt or good experience in 6 Sigma are preferred:
  basics mastered (process capabilities, MSA, SPC).
• Project management experience: implement, master and track timing plan, key performance indicators and action plan.
• Fluent English is mandatory.
• Good FMEA knowledge
• Good GMP knowledge or Medical device knowledge / ISO13485
• Good problem solving methodologies knowledge – e.g. QRQC
• Knowhow in all Microsoft office software, SAP and MS project
• Capacity to listen and understand needs & requirement
• Good analytical and synthesis skills
• Excellent relationship and knows how to work in a matrix environment
• Sense of responsibility
• Leadership, can federate people
• Willingness to travel : 25% (up to 50% depending on project phases)

Driving our future growth requires talented people. Sartorius is a dynamic organization suited to people who want to showcase skills, be recognized for expertise and thrive in a vibrant and innovative environment.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex or national origin. We are also an equal opportunity employer of individuals with disabilities and protected veterans.

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We look for employees who would like to grow with us and move the innovative life sciences sector forward. In the process, we focus on agile project work, mutual support within teams and working as equals. Sartorius thrives as a company with people who give their very best every day and who are eager to develop personally and professionally.

Further insights into our world of work can be found here.