Senior Manufacturing Engineer

Manufacturing Engineer

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.

Lead initiatives aimed at:

• Ensuring that automated equipment/systems installed in production areas function according to specifications and are fully prepared for qualification activities and hand-off to production.
• 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 and packaging 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.
• Establish New Equipment and Processes - Uses technical and business knowledge and expertise to support Operations in the design, maintenance, installation, scale-up, optimization, automation, trouble shooting and validation of manufacturing processes or equipment. Aids in the preparation of user requirements, bid package, capital justification, and acceptance testing strategy for all new filling, packaging and manufacturing equipment.
• 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 cross-functional project teams 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 teams 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:

• 5-6 years of hands-on experience in a cGMP manufacturing environment with automated filling and packaging equipment. 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), adhesive bonding, drying methods and microdispensing preferred.
• Experience with injection molding of primary packaging components 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.
• A self-starter who has the ability and self awareness to understand the company's goals and project scope, enabling them to perform at a high level under minimal supervision and add value to the organization.

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

• 10-20%, based on business needs for the first 4-6 months. Travel includes Roche affiliates within the US and equipment suppliers both within and outside the US.
• Traveling would be once a month when needed.