Planet Pharma
A healthier future. Its 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.
Senior Manufacturing Engineer – Overview As a Senior Manufacturing Engineer you will plan and manage activities that shape the future of our production processes.
Responsibilities
Define precise specifications for new equipment and packaging components, aligning manufacturing capabilities with marketing objectives.
Apply engineering principles and financial acumen to enhance diagnostic manufacturing performance, champion cost reductions, and achieve high levels of quality and efficiency.
Lead initiatives aimed at ensuring automated equipment/systems installed in production areas function according to specifications and are prepared for qualification activities and hand-off to production.
Improve throughput yield and decrease mean time to repair (MTTR).
Ensure optimal manufacturing efficiency and drive business toward operational excellence.
Opportunity and Project Scope
Plans and manages projects within filling and packaging manufacturing streams; defines specifications for new equipment and packaging components in line with capabilities and marketing objectives.
Applies engineering principles and financial expertise to improve diagnostic manufacturing performance, promote cost reductions, and achieve optimum quality and efficiency.
Establish new equipment and processes; supports Operations in design, maintenance, installation, scale-up, optimization, automation, troubleshooting, and validation of manufacturing processes or equipment.
Aids in user requirements, bid packages, capital justification, and acceptance testing strategy for new filling, packaging, and manufacturing equipment.
Assess production processes for quality improvement opportunities and ensure compliance with cGMP and ISO standards.
Manufacturing documentation for product launches and manufacturing, including filling and packaging records, manufacturing records, packaging development purchasing specifications, and SOPs; initiate and oversee change requests.
Lead cross-functional project teams (typically 5–10 people) and manage communication, timelines, and issue resolution to meet project schedules.
Qualifications
Bachelor’s degree in Engineering or related technical discipline with 5–6 years of related experience, or MS with 4+ years of related experience.
Preferred experience:
5–6 years in a cGMP manufacturing environment with automated filling and packaging equipment; experience drafting and executing IQ/OQ/PQ protocols and test method validations.
Experience with surface treatment (plasma, CO2 cleaning), adhesive bonding, drying methods, and microdispensing.
Experience with injection molding of primary packaging components.
Experience managing projects in a matrixed organization; working knowledge of pharmaceutical/medical device/diagnostics cGMPs and FDA compliance; experience with design transfer for medical devices; experience implementing automation equipment; material science knowledge is a plus.
A self-starter with the ability to understand company goals and project scope, working with minimal supervision.
Work Environment The essential functions are performed in an environmentally controlled facility with a moderate noise level. The role may involve a mix of office and biotechnology laboratory environments and exposure to hazardous chemicals, blood-borne pathogens, and automated equipment. The position requires sitting, reaching, talking, standing, walking, and the ability to lift up to 35 pounds. Vision requirements include close, distance, color vision, and focus adjustment.
Travel Requirements 10–20%, based on business needs for the first 4–6 months; travel includes affiliates within the US and equipment suppliers both inside and outside the US. Traveling would be once a month when needed.
Contract Length One year. The contract could potentially extend to two years with a decision made prior to the end of the first year. Potential to hire full-time after 1 year if performance is proven.
Stipulations Potential for hire after 1 year term.
Pay rate is commensurate with experience. Target pay rate range is $60-80/hr.
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Senior Manufacturing Engineer – Overview As a Senior Manufacturing Engineer you will plan and manage activities that shape the future of our production processes.
Responsibilities
Define precise specifications for new equipment and packaging components, aligning manufacturing capabilities with marketing objectives.
Apply engineering principles and financial acumen to enhance diagnostic manufacturing performance, champion cost reductions, and achieve high levels of quality and efficiency.
Lead initiatives aimed at ensuring automated equipment/systems installed in production areas function according to specifications and are prepared for qualification activities and hand-off to production.
Improve throughput yield and decrease mean time to repair (MTTR).
Ensure optimal manufacturing efficiency and drive business toward operational excellence.
Opportunity and Project Scope
Plans and manages projects within filling and packaging manufacturing streams; defines specifications for new equipment and packaging components in line with capabilities and marketing objectives.
Applies engineering principles and financial expertise to improve diagnostic manufacturing performance, promote cost reductions, and achieve optimum quality and efficiency.
Establish new equipment and processes; supports Operations in design, maintenance, installation, scale-up, optimization, automation, troubleshooting, and validation of manufacturing processes or equipment.
Aids in user requirements, bid packages, capital justification, and acceptance testing strategy for new filling, packaging, and manufacturing equipment.
Assess production processes for quality improvement opportunities and ensure compliance with cGMP and ISO standards.
Manufacturing documentation for product launches and manufacturing, including filling and packaging records, manufacturing records, packaging development purchasing specifications, and SOPs; initiate and oversee change requests.
Lead cross-functional project teams (typically 5–10 people) and manage communication, timelines, and issue resolution to meet project schedules.
Qualifications
Bachelor’s degree in Engineering or related technical discipline with 5–6 years of related experience, or MS with 4+ years of related experience.
Preferred experience:
5–6 years in a cGMP manufacturing environment with automated filling and packaging equipment; experience drafting and executing IQ/OQ/PQ protocols and test method validations.
Experience with surface treatment (plasma, CO2 cleaning), adhesive bonding, drying methods, and microdispensing.
Experience with injection molding of primary packaging components.
Experience managing projects in a matrixed organization; working knowledge of pharmaceutical/medical device/diagnostics cGMPs and FDA compliance; experience with design transfer for medical devices; experience implementing automation equipment; material science knowledge is a plus.
A self-starter with the ability to understand company goals and project scope, working with minimal supervision.
Work Environment The essential functions are performed in an environmentally controlled facility with a moderate noise level. The role may involve a mix of office and biotechnology laboratory environments and exposure to hazardous chemicals, blood-borne pathogens, and automated equipment. The position requires sitting, reaching, talking, standing, walking, and the ability to lift up to 35 pounds. Vision requirements include close, distance, color vision, and focus adjustment.
Travel Requirements 10–20%, based on business needs for the first 4–6 months; travel includes affiliates within the US and equipment suppliers both inside and outside the US. Traveling would be once a month when needed.
Contract Length One year. The contract could potentially extend to two years with a decision made prior to the end of the first year. Potential to hire full-time after 1 year if performance is proven.
Stipulations Potential for hire after 1 year term.
Pay rate is commensurate with experience. Target pay rate range is $60-80/hr.
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