Process Engineer II
Company: Resilience
Location: West Chester
Posted on: July 3, 2025
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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 www.resilience.com
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 Provide
engineering and project management services 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 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 environment 6. 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 8. 2 to 5 years’ experience
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 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, Columbus , Process Engineer II, Engineering , West Chester, Ohio
