Job Description
A career at Resilience is more than just a job - it's an opportunity to change the future.
Resilience is a technology-focused biomanufacturing company that's changing the way medicine is made. We're building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need.
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Position Summary & Responsibilities
Ensures there is 1 technical process with centerlines, critical process parameters, material fit for use, and operating procedures are clear and delivers a capable process
Leads the following continuous process improvement efforts: changeover reduction, yield improvements, OEE improvements, maintenance reliability and waste reduction for improvement of automated pharmaceutical manufacturing equipment
Ensures success criteria for technology transfer and validation is clear and the process is capable for the merge into the Manufacturing/Facility process
Generates a variety of URS, FAT, SAT, commissioning and IQ/OQ/PQ protocols/ reports
Coordinate and support Manufacturing/Facility improvement initiatives that define equipment data, equipment capabilities, utilization, efficiencies and obsolescence. Manages life cycle of assets.
Maintain external technical relationships and collaborates with equipment and material suppliers
Identify, develop, generate and manage implementation of appropriate change controls to improve processes and address root causes identified in investigations
Perform and maintain risk management activities for new and existing processes / equipment
Initiate deviations and performs/facilitates the technical investigations and assessment of impacts
Authors and review documents including Standard Operating Procedures, Batch Records, Rework procedures and other forms. Author, review and approve validation and change control documents such as master plans, protocols, summary reports and change requests
Provides input and develops user requirements for new asset procurement
Provide engineering and project management services
Assist in the development of project justification and engineering proposals including providing input for capital planning process
Identify and support technical training requirements for Operations/Engineering/Maintenance for new and existing processes/equipment
Perform routine validation and periodic reviews activities
Supports and leads technical trouble shooting.
On-call support as required
Key contact for regulatory inspections as technical process owner
Participates in annual product review process
Participates in biennial critical systems review process.
Responsible for process validation required as a result of changes to validated processes within Manufacturing.
Minimum Qualifications
1. Experience in GMP or regulated production environment
2. Training or experience in the applicable following technologies: mechanics, hydraulics, pneumatics, vacuum technology, electronics, programmable logic controllers, HMI, Historian/reporting, computerized systems, vision systems, refrigeration, test equipment for electrical and mechanical trouble shooting, aseptic/controlled environment, unit operations, formulation, packaging, process validation, cleaning validation, technology transfer, change control, applied statistics
3. Proficiency in at least one of the following disciplines: automation/ controls, aseptic/packaging equipment, process/materials, maintenance, validation
Preferred Qualifications
1. Bachelor's Degree in Engineering, or related science
2. Project management
3. Uses their insight to challenge and adapt current approaches/ways of doing things
4. Experience in Six Sigma/ analytical trouble shooting skills
5. Experience working in a LEAN manufacturing environment6. Expertise in more than one of the following disciplines: automation/ controls, aseptic/ packaging equipment, process/materials, maintenance, validation
7. Ability to coach and mentor peers
#LI-RM
Resilience is an Equal Employment Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender perception or identity, national origin, age, marital status, protected veteran status, disability status, physical or mental disability, genetic information, or characteristic, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state, and local laws. Requests for reasonable accommodation can be made at any stage of the recruitment process.
Resilience offers employees a robust total rewards program including equity, an annual cash bonus program, a 401(k) plan with a generous company match and our benefits package which is thoughtfully designed to support our employees with great healthcare (including medical, dental and vision), family building benefits, life and disability insurance, flexible time off, paid holidays, other paid leaves of absence, tuition reimbursement and support for caregiving needs. Our target base pay hiring range for this position is $80,000.00 - $121,250.00 per year. Actual base pay is dependent upon a number of factors, including but not limited to, the candidate's geographical location, relevant experience, qualifications, skills and knowledge. Excited about Resilience and the biomanufacturing revolution? We encourage you to apply and start a conversation with one of our recruiters.
RESILIENCE (National Resilience, Inc.), is an equal opportunity employer. Employment decisions are made without regard to race, color, religion, national origin, gender, sexual orientation, gender identity, age, physical or mental disability, genetic factors, or military/veteran status or any other characteristics protected by law. EEO Minorities/Women/Disabled/Veterans
