Senior Validation Engineer
Company: Tri Pac, Inc.
Location: South Bend
Posted on: November 15, 2019
Tri-Pac, Inc. a contract development and manufacturing company
(CDMO) specializing in liquid and aerosol filling for
pharmaceutical marketers, is seeking an experienced Senior
Validation Engineer for immediate addition to our fast growing
team. The position is in South Bend, Indiana.
- Perform qualification of manufacturing equipment (liquid
aseptic and aerosol aseptic), facility and utility systems
(including CIP/SIP qualification), cleaning validation, and process
validation. Scope of responsibilities includes drafting of
qualification protocols and summary reports, field execution, and
- 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
- 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
- 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.
Minimum Bachelor's Degree in Engineering or Science discipline,
advanced degree is a plus
- Minimum 7+ years of relevant validation experience in regulated
industry. The engineer is expected to be proficient in at least 4
of 7 validation core expertise.
- Expertise in the following areas is must:
Facility/Equipment/Utility Qualification, Cleaning/Sterilization
Cycle Development, Cleaning Validation, and Process
- Familiar with applicable domestic and international GMP
regulations impacting validation requirements (e.g. 21 CFR
- 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
- 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
- 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
- Expert Microsoft Word / Powerpoint and Intermediate Microsoft
Excel skills are required.
- Understanding of basic statistics, acceptance sampling, and
familiar with statistics software
- Strong 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 Qualification
- Equipment Qualification
- Utilities Qualification
- Cleaning Validation
- Process Validation
- Sterilization Validation
- Computerized System Validation
Benefits Competitive Salary & Packages, Vacations, Child Care,
insurance reimbursement and Continuous Training. Work where you are
Happy. Tri-Pac, Inc. also recognizes the importance of continuing
education and offers Education Assistance to our employees to
encourage continued personal development and growth.
Please Take a Moment To Visit Our Website
Tri-Pac, Inc. is an Equal Employment Opportunity / Affirmative
Action EmployerThank you for your interest and consideration of a
career with Tri-Pac, Inc.
Keywords: Tri Pac, Inc., South Bend , Senior Validation Engineer, Engineering , South Bend, Indiana
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