Validation Engineer III, CPV
Company: Resilience
Location: West Chester
Posted on: April 18, 2024
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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 Position Summary &
ResponsibilitiesThis position: Validation Engineer III, Performs,
leads and troubleshoots the Continued Process Verification of the
site. Specializing in general validation support.* Author, Review
and approve documentation needed for Continued Process Verification
(CPV).* Prepare documentation of activities, actions, and/or
results.* Monitor records to ensure compliance with regulatory
requirements.* Complete required training.* Ensure proper
documentation practices during job activities.* Answer compliance
and process questions from others.* Communicate policies and
procedures to employees.* Gather, organize, and communicate
operational information to others.* Communicate priorities and
progress to team on a continuing basis.* Read SOPs (Standard
Operating Procedures) and excerpts from technical documentation.*
Guide others on SOPs (Standard Operating Procedures), control
documents, and/or other work instructions.* Initiate appropriate
action when process deviations occur.* Attend inter-departmental
meetings to discuss matters involving the coordination of multiple
departments.* Coordinate with representatives from other
departments.* Interact with other departments to ensure that
product is inspected under validated conditions.* Interact with
other departments to implement corrective/preventative actions.*
Participate in cross-functional teams to meet strategic goals.*
Review and approve OCMs, change controls, and document revisions.*
Attend team meetings to discuss progress, initiatives, and/or other
matters.* Read, understand, and comply with cGMP (Good
Manufacturing Practices) and SOPs (Standard Operating Procedures),
including general safety, lock outs and so on.* Read and interpret
diagrams, drawings, and other schematics.* Facilitate the execution
of validation protocols for processes, equipment, packaging, and/or
cleaning.* Consult cross-functionally as an SME (Subject Matter
Expert) on systems and/or processes within a functional area.*
Participate in troubleshooting activities.* Lead process
improvement activities and teams to meet strategic goals.*
Facilitate communication between management and non-management.*
Investigate deviations.* Close out deviations, CAPAs, and/or pAFCAs
as needed.* Identify temporary and permanent fixes to address
issues.* Interact with regulatory agency personnel during audits
and inspections.* Write, review, and revise SOPs (Standard
Operating Procedures) and/or work instructions for cGMP (Good
Manufacturing Practices) manufacturing of commercial product.* Read
technical publications and manuals and write associated
procedures.* Approve new and updated SOPs.* Occasionally Provide
"off shift" support (for example: night shift support if you
normally work day shift).* Assist process engineering and managers
with improvement projects.* Recommend compliance resolutions to
management.* Review and approve requirements, specifications,
drawings, coding procedures, and guidelines.Minimum
Qualifications:* Experience in validation or process engineering.*
Demonstrated experience in a manufacturing or processing setting*
Ability to expertly read and interpret drawings and diagrams*
Strong analytical skills, with keen attention to detail* Strong
communication skills, both written and verbal* Demonstrated
knowledge of health and safety guidelines* Good report writing
skills* Good problem-solving abilities* Ability to prioritize own
time and workloadPreferred Qualifications:* Bachelor's degree in
engineering, Computer Science, or a validation related discipline*
Experience in a regulated or cGMP environment.* Strong knowledge of
analytical methodology and instrumentation* Strong knowledge of
chemical process safety, validation, and quality
assuranceResilience 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 $85,000.00 - $122,500.00 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, Fairfield , Validation Engineer III, CPV, Engineering , West Chester, Ohio
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