Senior Validation Engineer - Indianapolis (Onsite)
Company: PACIV
Location: Indianapolis
Posted on: March 20, 2023
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Job Description:
PACIV, a global leader in industrial automation solutions with
offices in Puerto Rico, United States, and Ireland, and servicing
the Life Sciences, F&B and Utilities industries is looking for
a full-time employed Senior Validation Engineer based at our USA
office (Indianapolis) - -
Job Description :
The Senior Validation Engineer will be responsible for the
preparation, review, and approval of quality and validation -
related documentation and ensuring compliance during manufacturing
operations. This includes full execution of the System Development
Lifecyle (SDLC) for an array of equipment and systems supporting
manufacturing, laboratories and/or packaging processes. - Specific
assignments will vary based on the experience and expertise of the
successful candidate, and requirements and expectations of the
client. - -
Position Requirements
Bachelor's degree in Engineering or Technical discipline
Minimum of eight (8) years Commissioning, Qualification, and/or
Validation experience within technical/regulated industries
Experience and in-depth understanding of all system lifecycle
deliverables from Commissioning & Qualification (C&Q) and
Computer System Validation (CSV) documents through System
Retirement. This includes deliverables such as Planning (Project
Validation Plan or Validation Master Plan), User/Functional
Requirements, Design Specifications, Design Qualification (DQ),
Commissioning (FAT, SAT, Startup), Qualification Test Protocols
(IQ/OQ/PQ), Process Validation (PV), Final Reporting, and support
documentation (i.e. Traceability Matrices, SOP development, PMs,
calibration, etc.)
Experience with standard industry Process, Packaging,
Facilities/Utilities, which may include: Control Box equipment
(e.g. PLCs, HMIs, ladder logic, etc.), Packaging
Labelers/Cartoners, BMS/CMS Systems (e.g. AHUs, Metasys, NAE
controllers, etc.), Lab Equipment (e.g. Homogenizers,
Spectrophotometers, Balances, Freezers/Coolers, etc.) and Automated
in-process Filling, Assembly, and Delivery lines.
Knowledge and experience with electronic document retention systems
for approval, change control, and archiving purposes (i.e. Regulus,
SharePoint, The Box, etc.)
Knowledge of industry CSV and C&Q expectations and requirements
(e.g. FDA guidelines, USP, GAMP 5, ISO, etc.) -
Actively participate among cross-functional teams and lead project
initiatives to ensure projects are delivered on time and to
required quality standards
Ability to lead, manage and execute large product launch/release,
small capital projects, and process improvement changes related to
the manufacturing systems within the site
Desired Hard Skill Sets :
CSV experience, specifically around CFR Part 11 Electronic Record
and Signatures
Experience with Data Historian, Migration, and Historian systems
(i.e. OSI PI)
Project Management experience with the ability to lead and drive
projects to completion autonomously
Desired Soft Skills:
Works well with others, within a team and takes accountability
Can handle a high-pressure, high-stress work environment
Result driven and self-motivated
Strong interpersonal and communication skills (verbal and
presentation)
Organized, with strong computer literacy such as MS Project, Excel,
etc.
Other Requirements
Location: - Indianapolis, IN
Travel: Up to 10% of the time to various suppliers, collaborators,
and OEM sites outside of Indianapolis
Compensation
Competitive Salary and Benefits Package (Medical, Dental, Vision,
and Life Insurance, 401K Plan, Holidays, Vacation, Sick Time
pay.
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Keywords: PACIV, Indianapolis , Senior Validation Engineer - Indianapolis (Onsite), Engineering , Indianapolis, Indiana
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