Lyophilization Systems Engineer

OUR TEAM:

We are a team with expertise in lyophilization and vacuum-drying, empowered to solve problems with innovation and flexibility. Success requires motivation, strong collaboration, effective communication, and the ability to handle ambiguity in a fast-paced, regulated environment. If you share these skills (or attributes) and are ready for new opportunities, join us in managing and optimizing processes and driving new product development to consistently deliver safe, high-quality, and effective products that exceed customer expectations.

YOUR ROLE:

In this dynamic role, you will support the operation, maintenance, troubleshooting, and support of lyophilization and vacuum-drying equipment, while coordinating production runs and ensuring accurate batch records. You will also champion continuous improvement through data-driven process optimization, project management, and strong cross-functional collaboration, ultimately enhancing product quality and upholding regulatory excellence.

CORE DUTIES:

Equipment Operation and Maintenance:

1. Operate, clean, and maintain lyophilization, vacuum drying, and steam generation equipment.

2. Coordinate and execute preventive maintenance, troubleshoot issues, and repairs with internal teams and external contractors.

3. Monitor system performance, proactively addressing issues to ensure operational reliability.

4. Serve as the primary on-call resource for process and equipment-related concerns.

5. Maintain accurate documentation of equipment performance and processes.

Production Coordination & Batch Record Review:

1. Coordinate the lyophilization process by overseeing the delivery of bulk materials to the dispensing lines, supporting product finishing, and executing lyophilization production activities.

2. Plan and monitor unique production runs by coordinating with Bulk Production, Product Finishing, and Materials Management while owning and executing lyophilization activities.

3. Review of production batch records for accuracy and completeness.

4. Collaborate with QA for batch record reviews, non-conformances (NCs), and quarantine review and disposition records (QRDRs).

Process Design and Improvement:

1. Collaborate with Validation and Quality Assurance to define equipment specifications and monitor performance of processes.

2. Improve lyophilization and related manufacturing processes through data-driven analysis and optimization.

3. Identify and implement continuous improvement initiatives to enhance product quality and lyophilization manufacturing efficiency.

Project Management and Collaboration:

1. Work within cross-functional teams to develop and implement change control.

2. Work closely with Materials Management, Bulk Production, Customs, Product Finishing, and R&D teams to coordinate and execute lyophilization project implementation and maintenance.

3. Support automation initiatives to improve lyophilization efficiency for high-demand products.

4. Communicate project updates and technical requirements effectively to stakeholders.

Authoring and Documentation:

1. Author, update, and approve manufacturing protocols and quality system documentation.

2. Execute and maintain required manufacturing documentation.

3. Support training on lyophilization operations, protocols, and documentation.

4. Ensure compliance with regulatory standards.

5. Demonstrates inclusion through their own words and actions and is accountable for a safe workspace. Acts with kindness, curiosity and respect for others.

6. Embracing and being open to incorporating Promega's 6 Emotional & Social Intelligence (ESI) core principles in daily work.

7. Understands and complies with ethical, legal and regulatory requirements applicable to our business.

KEY QUALIFICATIONS:

1. Bachelor's degree in chemical, Bioprocess, or Mechanical Engineering (or equivalent experience) or a minimum of 5 years of experience in lyophilization and vacuum-drying operations, or related processes.

2. Strong mechanical aptitude and problem-solving skills.

3. Experience with regulated manufacturing processes and equipment.

4. Ability to analyze technical data and drive process improvements.

5. Excellent organizational, communication, and teamwork skills.

PREFERRED QUALIFICATIONS:

1. Experience designing and implementing regulated process systems (e.g., lyophilization, CIP/SIP, USP water).

2. Knowledge of automation engineering (e.g., ANSI/ISA S-88 Batch control levels).

3. Familiarity in statistical analysis for process development.

4. Experience with equipment validation and process control documentation.

5. Working knowledge of AI tools such as ChatGPT or Copilot in a manufacturing environment.

PHYSICAL DEMANDS:

1. Ability to work flexible hours based on production needs.

2. Work in production and lab environments, handling chemical, biological, and packaging materials.

3. Lift and transport items up to forty pounds; heavier loads moved using dollies or pallet jacks.

4. Work in controlled environments, including low-temperature settings (-20C).

5. Perform tasks requiring mobility and dexterity, including ladder use and low-position work.

6. Occasional travel for supplier or vendor interactions.

At Promega, we are committed to building a diverse workforce that reflects the communities we serve and creating a culture where everyone belongs. As an Equal Opportunity Employer, we welcome and encourage applications from all backgrounds, ensuring that employment decisions are made fairly and equitably.