Responsibilities

The Sr. Quality Engineer, Validation is responsible for the creation and execution of validation protocols for facilities, utilities, equipment, and process qualifications in compliance with Quality System requirements and recognized international standards. The incumbent will work collaboratively with Quality, Manufacturing, Operations, and Process Engineering teams to validate new equipment and processes, assess changes to existing equipment and processes, and improve product realization processes and practices. This position will develop and implement validation protocols and procedures used by Sysmex America, Inc. (SAI), Sysmex Reagents America, Inc. (SRA), and Sysmex Brazil facilities, and champion global validation system harmonization efforts.

Essential Duties and Responsibilities:

Drive validation activities for new or modified cGMP equipment and processes using technical expertise and knowledge of 21 CFR Part 820, GHTF QMS – Process Validation Guidance (GHTF/SG3/N99-10:2004), and ISO 13485.

Assist in equipment design and User Requirement Specifications (URS).

Create & maintain Validation Master Plan (VMP).

Write, review and approve IQ, OQ and PQ protocols for manufacturing facilities, utilities, equipment, and processes following established standards and templates.

Prepare report packages for completion of commissioning, qualification and validation activities.

Lead root cause investigations relating to validation and qualification activities.

Perform field/site activities pertinent to FATs and SATs, vendor start-up testing, and execution of commissioning, qualification and validation protocols.

Generate risk management deliverables such as System Impact Assessments, Criticality Assessments, and Risk Management Reports.

Manage Engineering Change Control process in support of company business, the Quality Management System (QMS), and regulatory compliance.

Chair Validation Review Board Meetings (VRB) and participate as a member.

Conduct analytical instrument/method validation, including computerized system validation, if applicable.

Champion process improvements within the process validation process.

Physical Risk: No unusual exposures to risk.

Physical Demands: Light physical effort. Routine handling of objects up to 20 pounds; prolonged (at least 50% of time) sitting, standing, keyboard or CRT work. May require periods of moderate discomfort due to noise, dust, lighting and/or other conditions.

Percentage of Travel: 10%

Qualifications

• Bachelor’s Degree in Engineering or Science required plus 5-7 years of experience in the Medical Device industry or relevant business experience within Quality Assurance or Validation cGMP compliance.

• Minimum 5 - 7 years of related experience in Quality Engineering, Manufacturing Engineering, and/or Validation Engineering in a regulated industry (medical device or pharmaceutical).

• ASQ CQA or CQE a plus.

• Knowledge of cGMP, 21CFR820, and ISO 13485 requirements.

• IVD Manufacturing experience preferred.

• Prior leadership experience is preferred.

• Technical writing proficiency (e.g., protocols, analytical reports, SOPs, Test Methods, procedures).

• Working knowledge of risk management (pFMEAs), SPC, Capability Analysis, Gage R&R, Attribute Agreement Analysis, DOE, and other quality engineering tools such as statistical data analysis, and inspection techniques.

• Experience in creation and execution of FAT, SAT, IQ, OQ and PQ protocols for GMP Utilities, Equipment, Facilities and Processes.

• Understanding and application of 21 CFR 820 Medical Device Quality System Regulation, especially 21 CFR 820.70 for equipment qualification and 21 CFR 820.75 for process validation. Experience with the validation life cycle (planning, protocol writing, execution, report writing).

• Experience with Cleaning, Process, Analytical Methodologies, and other validation activities and processes is beneficial.

• Experience with Risk-Based Approach to Commissioning and Qualification is beneficial.

• Experience in GMP/Validation with knowledge and understanding of pharmaceutical Design/Build/Commission/Validate processes and regulatory requirements.

• English.

• Proficiency with Microsoft Office applications and statistical software such as Minitab.

• Strong Interpersonal Skills.

• Solid problem analysis and decision-making ability and leadership skills.

• Ability to define problems, collect data, establish facts and draw valid conclusions.

• Solid verbal and written communication with the ability to present information clearly and effectively, and respond to questions/concerns in an individual or group setting.

• Strong organizational skills along with attention to detail.

• Ability to work both independently and collaboratively with small, cross-functional teams.

• Ability to obtain cooperation, develop a consensus and lead or influence cross-functional teams.

• Strong analytical skills and problem-solving ability.

• Must be able to work independently.

• Demonstrated ability to work in a team environment and manage workload to meet deadlines.

The salary range for this role is $94,220-$148,060. Within this range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. The total compensation package for this position also includes a choice of health care plan (medical, vision, and dental insurance), an annual incentive bonus, paid time off, parental leave, bereavement leave and a 401(K) for all eligible employees.