Principal Engineer, Sterile Filling

Par Health; Rochester (MI); Presencial; USD 120.000 - 150.000; Jornada completa

Descripción de la vacante

Par Health in Michigan seeks a Site Isolator Lead Engineer to own the life-cycle management of isolator systems, including qualification, operation, maintenance, and continuous improvement at the Sterile Products site. This role leads with strategic direction and partners across Operations, Quality, and R&D to ensure compliant, high-quality manufacturing.

You will drive engineering programs, mentor engineers, and advance facilities and equipment reliability while maintaining a strong safety

Formación

• Bachelor's degree in an engineering field with progressive technical experience.
• Experience in aseptic processing and pharmaceutical manufacturing is preferred.
• Strong leadership and cross-functional collaboration capabilities.

Responsabilidades

• Lead capital investment planning and qualification of isolator technologies.
• Provide technical oversight for isolator filling lines and projects.
• Ensure FDA/cGMP compliant design, FAT/SAT, and validation activities.
• Collaborate with Operations, Quality, Validation, and PM for project delivery.
• Drive continuous improvement to achieve OEE targets and reliability.

Conocimientos

Leadership

Analytical thinking

Problem solving

Continuous improvement

Teamwork

Interpersonal skills

Oral communication

Written communication

Educación

Bachelor of Science in Mechanical, Materials, Equipment, Electrical or Chemical Engineering

Descripción del empleo

At Par Health, we believe great healthcare is built on getting the essentials right. We’re looking for passionate, talented individuals who share our commitment to improving lives. With a global workforce, we lead with pride and purpose-prioritizing quality and safety while fostering a culture of continuous improvement, accountability, and teamwork. Elevating the Essentials isn’t just our tagline, it’s the higher standard we live by every day.

Summary of Position

The Site Isolator Lead Engineer serves as the primary Subject Matter Expert (SME) for Filling Technologies and is responsible for the full life-cycle management of isolator systems, including qualification, operation, maintenance, and continuous improvement activities. This role provides advanced technical leadership in the development and optimization of equipment, manufacturing processes, and facilities at the Par Health Sterile Products manufacturing site. The Lead Engineer is responsible for driving technical direction and partnering with cross-functional stakeholders including Operations, Quality, Technical Services, Engineering, EHS and R&D to identify, evaluate, and implement improvements that support operational excellence, compliance, and overall organizational objectives. This role serves as a member of the Engineering Leadership Team and provides strategic direction for isolator technologies across the site.

Responsibilities

• Lead capital investment planning, implementation, qualification, and maintenance of isolator technologies
• Leads engineering activities for all isolator and aseptic filling projects, including equipment upgrades, process improvements, and new technology implementation.
• Provide technical oversight to external engineering firms, contractors, and equipment suppliers of isolator filling lines.
• Ensure appropriate engineering lifecycle methodologies—including User Requirements Specifications (URS), Risk Assessments, Design Reviews, Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), Commissioning, Qualification, and Validation—are executed for isolator filling lines and related equipment
• Collaborate with Operations, Quality, Validation, and Project Management to successfully execute engineering initiatives.

Operations

• Collaborate with Manufacturing operations and at times lead agreed continuous improvement initiatives attributable to isolator filling lines to achieve OEE targets, optimize equipment reliability, capacity, and manufacturing performance
• Lead complex technical investigations and root cause analysis to resolve equipment issues and related process deviations, and while driving sustainable corrective actions.
• Ensure isolator systems and processes sustain maintenance, equipment reliability, and standardized operational practices.
• Serve as the primary technical liaison between the site and key equipment manufacturers and service providers, including Optima, SKAN, and Ziel.

Compliance & Quality

• Accountable for the compliance strategy and inspection readiness of all isolator technologies and associated filling systems.
• Proactively identify, assess, and mitigate equipment compliance and operational risks.
• Own the Quality Management System (QMS) performance for isolator technologies, ensuring timely execution of deviations, CAPAs, change controls, and investigations.
• Review, approve, and govern technical procedures, standards, and documentation for isolator technologies to ensure alignment with cGMP requirements and current regulatory expectations.
• Reinforce quality and compliance expectations for aseptic filling technologies and supporting equipment.
• Ensure engineering-related activities comply with FDA, EMA, and internal quality standards for isolator equipment lines.

Cross-Functional Collaboration

• Partner with Manufacturing, Packaging, Supply Chain, Technical Operations, Validation, Quality, Information Technology, and Research & Development to support operational improvements and new product introductions.
• Collaborate with Learning & Development to ensure sustainable training, qualification, and certification programs are developed for new and modified isolator equipment.
• Coordinate engineering activities with manufacturing leadership to ensure successful project execution and operational readiness.
• Support site Safety, Health, and Environmental (SHE) objectives while promoting a strong safety culture.

Leadership

• Contribute to the development of training and qualification programs for isolator technologies, ensuring technical competency across the organization.
• Build and strengthen site technical capability by developing engineering standards, mentoring technical staff, and sharing best practices.
• Provide technical coaching to engineers and cross-functional personnel.
• Serve as the site's technical authority for isolator technologies, influencing strategic decisions and driving innovation across manufacturing operations.
• Promote a culture of accountability, collaboration, continuous improvement, and operational excellence throughout the organization.

Education

• Bachelor of Science in Mechanical, Materials, Equipment, Electrical or Chemical Engineering, or a related technical degree plus progressive technical experience and demonstrated competence.

Experience

• Minimum of 10 years of progressive engineering experience within the pharmaceutical, biotechnology, or sterile manufacturing industry, including experience supporting aseptic filling operations.
• Minimum of 5-7 years of direct, contemporary experience with isolator technology and associated aseptic processing equipment, including CIP/SIP systems, compounding equipment, vial washers, depyrogenation tunnels, filling lines, cappers, lyophilizers, and process control systems.

Knowledge

• In-depth knowledge of the pharmaceutical plant operations and contemporary aseptic filling technologies.
• Aseptic processing and contamination control
• Sterile injectable manufacturing
• Facility and utility systems
• Reliability engineering
• Automation and process control
• Validation and qualification

Skills and Abilities

• Leadership - Exhibits confidence in self and others; Inspires and motivates others to perform well; effectively influences actions and opinions of others; Accepts feedback from others; Gives appropriate recognition to others.
• Analytical – Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement but not replace data; Designs work flows and procedures.
• Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skilfully; Develops alternative solutions; Works well in group problem solving situations; Uses reason even when dealing with emotional topics.
• Continuous Improvement – Embraces a continuous improvement mindset with familiarity to the lean/six sigma toolkit and ability to coach collaborative problem-solving using these tools
• Teamwork - Balances team and individual responsibilities; Exhibits objectivity and openness to others' views; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Able to build morale and group commitments to goals and objectives; Supports everyone's efforts to succeed.
• Interpersonal Skills - Focuses on solving conflict, not blaming; Maintains confidentiality; Listens to others without interrupting; Keeps emotions under control; Remains open to others' ideas and tries new things.
• Oral Communication - Speaks clearly and persuasively in positive or negative situations; listens and gets clarification; Responds well to questions; Demonstrates group presentation skills; Participates in meetings.
• Written Communication - Writes clearly and informatively; Edits work for spelling and grammar; Varies writing style to meet needs; Presents numerical data effectively; Able to read and interpret written information.

Physical Requirements

• Regularly lift and /or move up to 10 pounds and occasionally lift and/or move up to 50 pounds
• Climb ladders and work in high, precarious places up to elevations of 75 feet
• Regularly exposed to work near moving mechanical parts
• May be exposed to wet or humid conditions
• May be exposed to outdoor weather conditions
• Regularly exposed to high noise environments
• May be exposed to extremely dusty environments
• May be exposed to chemicals used in the manufacturing process

DISCLAIMER

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.

EEO Statement:

We comply with all applicable federal, state, and local laws prohibiting discrimination and harassment, and provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status, or genetic information, or any other classification protected by federal, state or local law. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.