Process Engineer II
Company: Resilience
Location: West Chester
Posted on: May 9, 2024
|
|
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.For more information, please visit 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 processIdentify 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
because of changes to validated processes within
Manufacturing.Minimum Requirements* 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.* Ability to develop proficiency in all the following
disciplines: automation/ controls, aseptic/packaging equipment,
process/materials, maintenance, validation.Preferred Background *
Bachelor's degree in engineering, or related science* Experience in
GMP or regulated production environment.* Experience in Project
management * Uses their insight to challenge and adapt current
approaches/ways of doing things.* Experience in Six Sigma/
analytical trouble shooting skills.* Experience working in a LEAN
manufacturing environment.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 $70,000.00 - $96,250.00 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.
Keywords: Resilience, Carmel , Process Engineer II, Engineering , West Chester, Indiana
Click
here to apply!
|