Validation Engineer
Company: Tri-Pac Inc
Location: South Bend
Posted on: March 18, 2023
Job Description:
- - - - - - - - - - - - - - - - - - - - - - - - - - -Validation
EngineerTri-Pac, Inc. a contract development and manufacturing
company (CDMO) specializing in in liquid and aerosol filling for
personal care and pharmaceutical marketers , is seeking an
experienced Validation Engineer for immediate addition to our fast
growing team. The position is in South Bend, Indiana and
on-site.Major Accountabilities:
Perform qualification of
manufacturing equipment (liquid aseptic and aerosol aseptic),
facility and utility systems (including CIP/SIP qualification),
computer system validation, cleaning validation, and process
validation. -Scope of responsibilities includes drafting of
qualification protocols and summary reports, field execution, and
data analysis.As needed coordinate and provide directions to
contract personnel performing validation activities.Support the
development and execution of FATs, SATs, DQ, IQ, OQ, PQ, and other
relevant life cycle documents leveraged to support validation
effort.Support the development and update of validation master
plans, validation project plans, SOPs, risk assessments, user
requirements, cleaning assessments, technical assessment
reports.Support cleaning and sterilization (including CIP/SIP,
manual cleaning, steam sterilization) development
activities.Support periodic requalification and revalidation
effort.Work independently and directly interface with personnel
from multiple departments including Technical Development,
Manufacturing, Engineering, Manufacturing Support, MAC, QC, and
QA.Support gap assessment/closure, corrective actions, and
compliance remediation related to Validation.As needed represent
Validation as SME (Subject Matter Expert) during regulatory or
customer inspections.As assigned mentor and manage fulltime
validation engineers/specialist and contractors.Education:Minimum
Bachelor's Degree in Engineering or Science discipline, advanced
degree is a plusExperience:
Minimum 2+ years of relevant
validation experience in regulated industry. -The engineer is
expected to be proficient in at least 3 of 7 validation core
expertise.Expertise in the following areas is must:
Facility/Equipment/Utility Qualification, Cleaning/Sterilization
Cycle Development, Cleaning Validation, Computer System Validation
and Process Validation.Familiar with applicable domestic and
international GMP regulations impacting validation requirements
(e.g. 21 CFR 11, 210, 211, 820).Familiar with current industry
guidance documents impacting validation best practices (e.g. FDA
Process Validation guidance, ISO 13485, and applicable PDA
Technical Reports).Experience with customer and regulatory
inspection.Strong understanding of quality risk management
principles, including best practice in risk based C&Q
approach.Hands on validation experience in developing validation
documentation and field execution.Project Management experience is
a plus.Aerosol production experience is a plus.Skills:
Familiarity and demonstrated
knowledge of biologics manufacturing processes, including
fermentation, purification, and bulk filling processes.Ability to
work independently in a matrix team environment, influence team
decisions, and exercise sound judgement in determining compliant
and robust validation approach.Ability to multi-task with
demonstrated track records in meeting deliverable timelines.Must
demonstrate the ability to think critically and analytically with
acumen for trouble-shooting and problem solving.Good interpersonal
skills, and accountable with excellent verbal and written
communication skills.Ability to function effectively and
independently in a fast-paced and dynamic
environment.Self-motivated and willing to tackle assignments and
development opportunities outside of job scope as needed.Ability to
interpret engineering and facility drawings such as facility
layouts, blueprints, material/process flow diagrams, and equipment
P&IDs.Expert Microsoft Word / PowerPoint and Intermediate
Microsoft Excel skills are required.Understanding of basic
statistics, acceptance sampling, and familiar with statistics
softwareStrong team player aligned with Grifols Corporate
Values.Hands on experience with facility/equipment/utility
qualification, cleaning validation, process validation, and
sterilization validation experience (steam sterilization and dry
heat depyrogenation) in GMP environment is required.Hands on
experience with CIP/SIP cycle development and qualification is
required.Validation Core Expertise:
Facility QualificationEquipment
QualificationUtilities QualificationCleaning ValidationProcess
ValidationSterilization ValidationComputerized System
ValidationCompetitive Salary/ Pay & Packages, Insurance, 401K, Life
Insurance, Disability (Long term/ Short term) and Continuous
Training.. Tri-Pac, Inc. also recognizes the importance of
continuing education and offers Education Assistance to our
employees to encourage continued personal development and
growth.Thank you for your interest and consideration of a career
with Tri-Pac, Inc.Tri-Pac, Inc. is an Equal Employment Opportunity
/ Affirmative Action EmployerTo Staffing & Recruitment Agencies:
Our Company does not accept unsolicited CV's or applications from
agencies. We are not responsible for any fees related to
unsolicited CV's or applications and explicitly reserve its right
to contact candidates presented in such unsolicited CV or
application. - -Powered by JazzHR
Keywords: Tri-Pac Inc, South Bend , Validation Engineer, Engineering , South Bend, Indiana
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