Process Engineer III Position Available In Chester, Pennsylvania

Job Description:

A career at Resilience is more than just a job – it’s anopportunity to change the future. Resilience is atechnology-focused biomanufacturing company that’s changing the waymedicine is made. We’re building a sustainable network ofhigh-tech, end-to-end manufacturing solutions to better withstanddisruptive events, serve scientific discovery, and reach those inneed. For more information, please visit www.resilience.com BriefJob DescriptionThe Process Engineer III leads improvementinitiatives as the technical expert and acts as the first line ofsupport for all project related work. Responsible for maintaining astrong relationship with TechnicalOperations and Quality areas, aswell as, collaborating within Manufacturing and the Facility andwith other Engineers. Serves as the single point of contact for alltechnical issues. Position Summary & Responsibilities Ensures thereis 1 technical process with centerlines, critical processparameters, material fit for use, and operating procedures areclear and delivers a capable process Leads the following continuousprocess improvement efforts: changeover reduction, yieldimprovements, OEE improvements, maintenance reliability and wastereduction for improvement of automated pharmaceutical manufacturingequipment Ensures success criteria for technology transfer andvalidation is clear and the process is capable for the merge intothe Manufacturing/Facility process Generates a variety of URS, FAT,SAT, commissioning and

IQ/OQ/PQ

protocols/ reports Coordinate andsupport Manufacturing/Facility improvement initiatives that defineequipment data, equipment capabilities, utilization, efficienciesand obsolescence. Manages life cycle of assets. Maintain externaltechnical relationships and collaborates with equipment andmaterial suppliers Identify, develop, generate and manageimplementation of appropriate change controls to improve processesand address root causes identified in investigations Perform andmaintain risk management activities for new and existing processes/ equipment Initiate deviations and performs/facilitates thetechnical investigations and assessment of impacts Authors andreview documents including Standard Operating Procedures, BatchRecords, Rework procedures and other forms. Author, review andapprove validation and change control documents such as masterplans, protocols, summary reports and change requests Providesinput and develops user requirements for new asset procurementProvide engineering and project management services Assist in thedevelopment of project justification and engineering proposalsincluding providing input for capital planning process Identify andsupport technical training requirements forOperations/Engineering/Maintenance for new and existingprocesses/equipment Perform routine validation and periodic reviewsactivities Supports and leads technical trouble shooting. On-callsupport as required Key contact for regulatory inspections astechnical process owner Participates in annual product reviewprocess Participates in biennial critical systems review process.

Responsible for process validation required as a result of changesto validated processes within Manufacturing. Minimum Qualifications1. 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 equipmentfor electrical and mechanical trouble shooting, aseptic/controlledenvironment, unit operations, formulation, packaging, processvalidation, cleaning validation, technology transfer, changecontrol, applied statistics 3. Proficiency in at least one of thefollowing disciplines: automation/ controls, aseptic/packagingequipment, process/materials, maintenance, validation PreferredQualifications 1. Bachelor’s Degree in Engineering, or relatedscience 2. Project management 3. Uses their insight to challengeand adapt current approaches/ways of doing things 4. Experience inSix Sigma/ analytical trouble shooting skills 5. Experience workingin a LEAN manufacturing environment6. Expertise in more than one ofthe following disciplines: automation/ controls, aseptic/ packagingequipment, process/materials, maintenance, validation 7. Ability tocoach and mentor peers Resilience is an Equal EmploymentOpportunity Employer. Qualified applicants will receiveconsideration 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, geneticinformation, or characteristic, or other non-job-relatedcharacteristics or other prohibited grounds specified in applicablefederal, state, and local laws. Requests for reasonableaccommodation can be made at any stage of the recruitment process.

Resilience offers employees a robust total rewards programincluding equity, an annual cash bonus program, a 401(k) plan witha generous company match and our benefits package which isthoughtfully designed to support our employees with greathealthcare (including medical, dental and vision), family buildingbenefits, life and disability insurance, flexible time off, paidholidays, other paid leaves of absence, tuition reimbursement andsupport for caregiving needs. Our target base pay hiring range forthis position is $80,000.00 – $121,250.00 per year. Actual base payis dependent upon a number of factors, including but not limitedto, the candidate’s geographical location, relevant experience,qualifications, skills and knowledge. Excited about Resilience andthe biomanufacturing revolution? We encourage you to apply andstart a conversation with one of our recruiters.