At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.
The Position
A healthier future. It's what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come.
Creating a world where we all have more time with the people we love.
That's what makes us Roche.
Join our dynamic team as a Senior Manufacturing Engineer, where you will plan and manage activities that shape the future of our production processes.
In this vital role, you will:
Define precise specifications for new equipment and packaging components, aligning manufacturing capabilities with marketing objectives.
Apply your expertise in engineering principles and financial acumen to enhance diagnostic manufacturing performance, champion cost reductions, and achieve the highest levels of quality and efficiency.
You will lead initiatives aimed at:
Reducing equipment downtime
Decreasing mean time to repair
Improving throughput yield
Your work will ensure optimal manufacturing efficiency and propel our company towards operational excellence. If you're passionate about driving innovation and efficiency in manufacturing, we invite you to apply and become an integral part of our success story.
The Opportunity
Plans and manages project activities for projects within filling, packaging and manufacturing streams. Defines specifications for new equipment and packaging components in accordance with manufacturing capabilities and marketing objectives. Applies engineering principles and financial expertise to improve diagnostic manufacturing performance, promote cost reductions and achieve optimum level of quality and efficiency.
Drive initiatives aimed at reducing equipment downtime, decreasing mean time to repair, and improving throughput yield, ensuring optimal manufacturing efficiency.
Establish New Equipment and Processes - Uses technical and business knowledge and expertise to support Operations in the design, maintenance, scale-up, optimization, automation, trouble shooting and validation of manufacturing processes or equipment. Prepares user requirements, bid package, capital justification, and acceptance testing strategy for all new filling, packaging and manufacturing equipment.
Package Development - Changes primary container, closure systems and secondary packaging to maximize quality, throughput and minimize cost. Develops package components and materials according to market requirements and manufacturing capabilities. Investigates and resolves problems related to packaging component materials.
Assess production processes for quality improvement opportunities, ensuring compliance with cGMP and ISO standards.
Manufacturing Documentation - Creation of a variety of documentation used to support product launches and manufacturing, including but not limited to filling records, packaging records, manufacturing records, packaging development purchasing specifications and SOP's. Initiate and oversee change requests and design change requests as needed.
Leads a cross-functional project team for complex projects within operations. Monitors, facilitates and prioritizes activities to meet project schedules. Activities include: communicating project status and critical path items to Operations' Management, develop and implement timeline plans, convening periodic meetings, issuing meeting agendas and minutes, monitoring team performance goals, and assisting in resolution of problems/critical issues. Works with and leads cross-functional team consisting of 5-10 people.
Who you are
Bachelor's degree in Engineering or related technical discipline with 5-6 years of related experience, background and industry, or M.S degree with 4+ years of related experience, background and industry.
Preferred experience:
?Prior experience in drafting and executing equipment qualification protocols (IQ/OQ/PQ) and test method validations preferred.
Experience with surface treatment (i.e. plasma, CO2 cleaning), laser bonding and microdispensing preferred.
Experience managing projects in a matrixed organization.
Working knowledge of pharmaceutical/medical device/diagnostics cGMPs and FDA compliance is strongly preferred.
Experience with design transfer activities for medical devices preferred.
Experience implementing automation equipment preferred.
Material Science knowledge is a plus.
WORK ENVIRONMENT
The essential functions of the job are usually performed in an environmentally controlled facility where the noise level in the work environment is usually moderate. This position may involve a combination of office and biotechnology laboratory environments. The employee may be exposed to hazardous chemicals, blood borne pathogens and automated equipment.
While performing the job duties, the employee is regularly required to sit; reach with hands and arms and talk or hear. The employee is frequently required to stand and walk. The employee may sometimes be required to lift and/or move up to 35 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision and ability to adjust focus.
Travel Requirements: 10-15%, based on business needs.
Relocation benefits are not available for this posting
The expected salary range for this position based on the primary location of New Jersey is $75,700-$140,500. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.
Benefits (https://roche.ehr.com/default.ashx?CLASSNAME=splash)
Who we are
A healthier future drives us to innovate. Together, more than 100'000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.
Let's build a healthier future, together.
Roche is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.
If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants (https://docs.google.com/forms/d/e/1FAIpQLSdZWlsbfQOvFVIQgHE_iDzWUTlhZvj6FytIzjS7xq6IGh1H5g/viewform) .
