Process Improvement Engineer

2 weeks ago

Spencer, Massachusetts, United States Katalyst Healthcares and Life Sciences Full time

Key Responsibilities:

Collaborates with a multidisciplinary team to streamline the New Product Introduction (NPI) process; this includes reviewing batch records and assisting area engineers to ensure compatibility within the manufacturing suites. Engages with technology transfer teams to create standardized and efficient clinical batch records.

Participates in established project initiatives as required.

Contributes to the development of meaningful Key Performance Indicators (KPIs) to facilitate continuous enhancement in technology transfer and new product introduction.

Organizes work assignments with minimal guidance to align with project timelines. Evaluates documents of varying complexity and oversees the review and approval process for operational documentation to meet project deadlines. Utilizes judgment within broadly defined procedures to determine suitable actions. Monitors ongoing issues and collects data for analysis. Analyzes information to propose solutions to general-level challenges. Presents potential solutions to management and, with support, formulates an implementation strategy.

Applies expertise, experience, and technical knowledge to comprehend specific site objectives, providing support for production initiatives, executing systems and procedures efficiently and in compliance, and assessing systems for potential improvements.

Operates within established frameworks to enhance Good Manufacturing Practices (GMP) compliance. Works under general supervision, adhering to established protocols. Decisions are evaluated for the soundness of technical judgment. Coordinates subgroup activities and collaborates with other sub-groups. Provides technical guidance and training to junior personnel.

Regularly interacts with subordinates and functional peer groups, requiring the ability to foster cooperation among others, and presents technical information regarding specific projects and schedules.


Qualifications:
Bachelor's Degree

in a relevant scientific discipline with a minimum of 5 years of experience in various aspects of manufacturing and production processes, along with strong writing capabilities.

Proficient knowledge in media and buffer preparation, cell culture, or purification processes for biological drugs is essential.

Competence in computer applications and scheduling is required.

Familiarity with safety protocols, quality systems, and current GMP as they pertain to equipment and process steps in the area of responsibility is necessary. Understanding of regulatory submissions is advantageous. Proficiency in the technology transfer process and familiarity with equipment and facility validation is expected. Must be adept at managing multiple tasks and maintaining composure under pressure. Demonstrates the ability to work effectively within a team environment. Maintains a high level of energy and professionalism in the workplace. Cultivates productive working relationships with clients, colleagues, cross-functional teams, and management.

  • Process Automation Engineer

    2 weeks ago

    Spencer, Massachusetts, United States AbbVie Full time

    Company OverviewAbbVie is dedicated to the discovery and delivery of innovative medicines and solutions that address significant health challenges today and in the future. Our focus is on making a substantial impact in various therapeutic areas, including immunology, oncology, neuroscience, and eye care, alongside our offerings in the Allergan Aesthetics...

  • Control Systems Engineer

    7 days ago

    Spencer, Massachusetts, United States AbbVie Full time

    Company OverviewAbbVie is dedicated to discovering and delivering innovative treatments that address significant health challenges today and prepare for future medical needs. Our commitment extends across various therapeutic domains, including immunology, oncology, neuroscience, and eye care, alongside our offerings in the Allergan Aesthetics portfolio. For...

  • Measurement and Instrumentation Specialist

    2 weeks ago

    Spencer, Massachusetts, United States AbbVie Full time

    Company OverviewAbbVie is dedicated to discovering and delivering innovative treatments that address significant health challenges today and in the future. Our commitment spans several therapeutic areas, including immunology, oncology, neuroscience, and eye care, along with our Allergan Aesthetics portfolio.Position OverviewThe Instrumentation Engineer plays...

  • Senior Manufacturing Engineer

    1 hour ago

    Spencer, United States Boston Scientific Full time

    About the RoleJob Summary: We are seeking a highly skilled Senior Manufacturing Engineer to lead initiatives for the daily support of products, processes, materials, and equipment. This individual will be responsible for leading the integration of new products within production, meeting new product integration timelines and production goals.Key...

  • Principal Process Engineer

    3 weeks ago

    Spencer, United States Gateway Recruiting, INC. Full time $132,000 - $135,000

    Job DescriptionJob DescriptionAbout the role: This role is for an experienced engineer to lead breakthrough technology development within the Process Development Team. The successful candidate for this position will have strong technical acumen, can influence product design, and will drive efficient cross-functional collaboration.  Responsibilities will...

  • Senior Process Development Engineer

    4 days ago

    Spencer, United States Boston Scientific Full time

    About the RoleBoston Scientific is seeking an experienced engineer to lead breakthrough technology development within the Process Development Team. The successful candidate for this position will have strong technical acumen, be able to influence product design, and drive efficient cross-functional collaboration.Key ResponsibilitiesAssess process...

  • Lead Process Development Engineer

    7 days ago

    Spencer, United States Gateway Recruiting, INC. Full time

    Job OverviewPosition Summary:This position seeks a seasoned engineer to spearhead innovative technology advancements within the Process Development Team. The ideal candidate will possess robust technical expertise, the ability to influence product design, and a commitment to fostering effective collaboration across various functions.Key...

  • Lead Process Engineering Specialist

    2 weeks ago

    Spencer, United States Gateway Recruiting, INC. Full time

    Job OverviewPosition Summary:This position seeks a seasoned engineer to spearhead innovative technology advancements within the Process Development Team. The ideal candidate will possess robust technical expertise, influence product design effectively, and foster efficient collaboration across various functions.Key Responsibilities:Evaluate process...

  • Lead Process Development Engineer

    6 days ago

    Spencer, United States Gateway Recruiting, INC. Full time

    Job OverviewPosition Summary:This position is designed for a seasoned engineer to spearhead innovative technology advancements within the Process Development Team. The ideal candidate will possess robust technical expertise, influence product architecture, and foster effective collaboration across various functions.Key Responsibilities:Evaluate process...

  • Senior Process Engineer

    1 month ago

    Spencer, United States Blueshift Materials, Inc. Full time

    Join the Blueshift Team!! Blueshift's bleeding edge thermal protection systems are used by some of the biggest OEM brands in the eVTOL, rocket, spacecraft and other aerospace, defense industries with challenging temperature or RF requirements. These products are based on AeroZero®, a thin, polyimide aerogel film that is used as the primary insulator in...

  • Senior Manufacturing Engineer

    4 weeks ago

    Spencer, United States Gateway Recruiting, INC. Full time

    Job DescriptionJob DescriptionAbout the role:The Senior Manufacturing Engineer leads initiatives for the daily support of products, processes, materials, and equipment and is responsible for leading integration of new products within production, meeting new product integration timelines and production goals (i.e., safety, quality, delivery, cost, and...

  • Senior Manufacturing Engineer

    2 months ago

    Spencer, United States Boston Scientific Full time

    Work mode: OnsiteOnsite Location(s): Spencer, IN, US, 47460Additional Location(s): N/ADiversity - Innovation - Caring - Global Collaboration - Winning Spirit - High PerformanceAt Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most...

  • Lead Manufacturing Engineer

    2 weeks ago

    Spencer, United States Gateway Recruiting, INC. Full time

    Job OverviewPosition Summary:The Senior Manufacturing Engineer is pivotal in driving initiatives that support product lines, processes, materials, and machinery. This role is crucial for the seamless integration of new products into production, ensuring adherence to integration timelines and production objectives, including safety, quality, delivery, cost...

  • Lead Manufacturing Engineer

    2 weeks ago

    Spencer, United States Gateway Recruiting, INC. Full time

    Job OverviewPosition Summary:The Senior Manufacturing Engineer is pivotal in driving daily operations concerning products, processes, materials, and machinery. This role encompasses overseeing the integration of new products into production while ensuring adherence to timelines and production objectives, including safety, quality, delivery, cost, and...

  • Sustaining Engineer II

    2 weeks ago

    Spencer, United States Cook Medical Full time

    Job Title: Sustaining Engineer IICompany: Cook MedicalThe Sustaining Engineer II will be responsible for activities associated with the upkeep of commercially available medical devices. This role includes tasks such as product and process improvements, risk evaluations, support for regulatory compliance, and enhancements to existing products and processes....

  • Sustaining Engineer

    3 months ago

    Spencer, United States Cook Group Full time

    Overview: Engineer 2, Sustaining, will perform activities related to sustaining commercially available products. These activities may include (but are not limited to) product/process remediation, risk analysis, regulatory approval support, and product/process improvements. The Engineer 2, Sustaining, will typically work independently with general supervision...

  • Sustaining Engineer 2

    3 months ago

    Spencer, United States Cook Medical Full time

    Overview Engineer 2, Sustaining, will perform activities related to sustaining commercially available products. These activities may include (but are not limited to) product/process remediation, risk analysis, regulatory approval support, and product/process improvements. The Engineer 2, Sustaining, will typically work independently with general...

  • Product Support Engineer 2

    2 weeks ago

    Spencer, United States Cook Medical Full time

    Job Title: Product Support Engineer 2Company: Cook MedicalThe Product Support Engineer 2 will be responsible for activities associated with the upkeep of commercially available medical devices. This role includes tasks such as product/process improvement, risk evaluation, support for regulatory compliance, and enhancements to existing products and processes....

  • Product Support Engineer 2

    7 days ago

    Spencer, United States Cook Medical Full time

    Job Title: Product Support Engineer 2Company: Cook MedicalThe Product Support Engineer 2 will engage in activities focused on the maintenance and enhancement of commercially available medical devices. Responsibilities may include product improvement initiatives, risk evaluations, assistance with compliance processes, and enhancements to existing products and...

  • Co-op Position in Manufacturing Engineering

    2 weeks ago

    Spencer, United States Cook Medical Full time

    Position Overview The Engineering Co-op Program offers a paid internship experience that provides valuable exposure to the field of Manufacturing Engineering. This role is designed to immerse students in a dynamic environment, focusing on both Manufacturing Engineering and Post-Market Engineering disciplines. Participants will benefit from a...

  • Spring Internship in Engineering at Cook Medical

    7 days ago

    Spencer, United States Cook Medical Full time

    Overview The Engineering Co-op Program offers a paid internship experience designed for aspiring engineers. This program provides a comprehensive 16-week rotation with responsibilities in Manufacturing Engineering and Post-Market Engineering. Participants will receive a housing stipend, access to a 401(k), fitness center, and various learning events,...

  • COOK Inc. Spring 2025 Manufacturing Engineering Co-op, Spencer, Indiana

    1 month ago

    Spencer, United States Cook Medical Full time

    Overview The Spring Engineering Co-op Program is a paid internship experience located in Spencer, Indiana. We offer a 16-week rotation with assignments in Manufacturing Engineering and Post-Market Engineering. This position includes a housing stipend, 401(k), fitness center access, learning events, capstone presentation, and more. All Co-op positions...

  • Product Support Engineer 2

    7 days ago

    Spencer, United States Cook Medical Full time

    Job Title: Product Support Engineer 2Company: Cook MedicalThe Product Support Engineer 2 will engage in activities aimed at sustaining commercially available medical devices. This role involves tasks such as product/process optimization, risk evaluation, support for regulatory compliance, and enhancements to existing products and processes. The Product...