Manufacturing Process Engineer II

1 week ago


Middletown, Virginia, United States Thermo Fisher Scientific Full time
Work Schedule

Standard (Monday to Friday)

Environmental Conditions

Ability to lift up to 40 lbs. independently, compliance with all Good Manufacturing Practices (GMP)

Safety Standards and Cleanroom Requirements:
No hair products, jewelry, makeup, nail polish, perfume, exposed piercings, or facial hair permitted.

Exposure to loud noises from equipment and machinery; prescriptive eyewear will be provided, no contact lenses allowed. A degree of Personal Protective Equipment (PPE) is necessary (safety glasses, gowns, gloves, lab coats, ear plugs, etc.)



Job Overview


As a member of Thermo Fisher Scientific, you will engage in impactful work that contributes positively on a global scale.

Join a team of over 90,000 colleagues dedicated to bringing our Mission to life every day, enabling our customers to create a healthier, cleaner, and safer world.

Here, you will find the tools and resources to achieve your career aspirations and help advance scientific progress by developing solutions for some of the most pressing challenges, such as environmental protection, food safety, and cancer research.


Location/Division:
Middletown, VA/Clinical Diagnostics Division (CDD)

The CDD is committed to being the most trusted partner for our customers by delivering innovative diagnostic solutions that enhance patient outcomes.

We aim to accomplish this by designing, developing, and providing products and capabilities that maximize value, quality, and efficiency for the In Vitro Diagnostics (IVD) market.


Key Responsibilities:
- Enhance production line automation Overall Equipment Effectiveness (OEE) within a Value Stream by employing innovative strategies and optimizing machine performance.

- Provide technical guidance and facilitate Root Cause Analysis, Focused Improvement, and Failure Mode and Effects Analysis (FMEA) to support Filling and Packaging Operations.

- Collaborate in team design reviews to create technical solutions that fulfill customer requirements and ensure successful outcomes.

- Maintain effective communication with the project team to regularly monitor progress and address any challenges.

- Identify, evaluate, and resolve deficiencies throughout a system's life cycle to enhance processes and products.

- Assess operational safety, reduce workplace hazards, and recommend new software, tools, or equipment to meet business objectives.

- Design and/or procure equipment and oversee their performance to guarantee uninterrupted operation of mechanical and electrical systems.

- Coordinate the manufacturing launch for new or revised products/processes, including the training and deployment of team members.

- Review and approve drawings, manufacturing instructions, and other documentation to ensure compliance and quality standards.

- Prepare and manufacture prototypes and participate in design reviews utilizing concurrent engineering principles.

- Ensure equipment qualification and generate necessary documentation in compliance with FDA regulations.

- Support Lean Manufacturing and Continuous Improvement initiatives within the assigned production area.

- Assist the Packaging Engineering Team with packaging enhancements and cost-saving measures.

- Meet individual performance expectations with a focus on Quality, Safety, and Delivery.

- Ensure adherence to Good Manufacturing Practice (GMP) standards.

Qualifications:
- Hands-on experience with GMP liquid filling, packaging, vision systems, and robotic manufacturing processes.

- Supervise existing automation processes, implementing changes to enhance production line output.

- Experience with root cause analysis and familiarity with machining tools and handheld equipment.

Education:
- Bachelor of Science in Engineering or a related field with 2 years of direct experience preferred.

- High School Diploma/GED with 6+ years of experience required.

- Proficiency in engineering graphics, such as 2D AutoCAD and 3D Solidworks, is essential.

- Familiarity with Microsoft Office applications, including Excel and Outlook, is also required.

Physical Requirements / Work Environment:
Daily presence in a GMP manufacturing environment necessitating the use of designated PPE. The role involves various activities such as sitting, standing, and climbing stairs. Physical strength may be required for occasional lifting and/or moving of items up to 50 pounds.

Benefits

We offer competitive compensation, an annual incentive plan bonus, healthcare, and a comprehensive range of employee benefits. Thermo Fisher Scientific provides employment within an innovative, forward-thinking organization, along with exceptional career and development opportunities. We foster an exciting company culture that embodies integrity, intensity, involvement, and innovation.

Our Mission is to empower our customers to create a healthier, cleaner, and safer world. Discover why our colleagues highlight five reasons to work with us.

As one team of over 100,000 colleagues, we share a common set of values - Integrity, Intensity, Innovation, and Involvement - collaborating to accelerate research, tackle complex scientific challenges, drive technological innovation, and support patients in need.

#StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds, and perspectives are valued.


Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other legally protected status.



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