Validation Engineer
Company: PACIV-USA, LLC
Location: Concord
Posted on: January 26, 2023
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Job Description:
Position: Validation Engineer (Level I, II and Sr)Office
Location: USA (North Carolina) ONSITE POSITIONPACIV, a global
leader in industrial automation solutions with offices in Puerto
Rico, United States, and Ireland, and servicing the Life Sciences,
F&B, WTP/WWTP and Utilities industries is looking for a
full-time employed Validation Engineer based out of our USA office
(North Carolina).Job Description:The Validation Engineer role
pertains to Commissioning and Qualification activities being
managed onsite at our client's facilities in North Carolina
(Raleigh/Durham and Charlotte). These C&Q activities involve
the Verification of new processes and systems which support
production facilities in an FDA-regulated and GMP-governed
Pharmaceutical manufacturing environment. These systems include the
following: Automated Asset Delivery Systems and Applications (i.e.
Dry and Wet/API assembly, Visual Inspection Systems, etc.)
Packaging Systems and Applications (i.e. Palletizer, Cartoners,
Labelers, etc.) Utility Systems and Applications (i.e. Clean Steam,
Parts Washers, Autoclaves, etc.)This role will be integrated with
our new business objective and team, PACIV-NC (North Carolina),
which is being developed and assembled to support multiple clients
in the ever-emerging Life Sciences and Biotechnology sectors in
RTP. The primary objective of the PACIV-NC team will be supporting
our client's commercial facilities that manufacture multiple
commercial and clinical bulk drug substances by providing seamless
Validation support and expertise to Quality and Manufacturing
operations and their respective groups.Job Responsibilities Become
familiar with the site Quality and Manufacturing procedures.
Complete client-assigned training curriculum and maintain training
at 100% Draft and update C&Q related deliverables Track and
bring to closure C&Q related action items Provide guidelines
and educate business partners on the appropriate application of
Validation and Verification practices Review and/or approve
documents as outlined in the C&Q Plan Monitor C&Q process
metrics for the project Identify potential process changes for
Continuous Improvement Support Design Review sessions (to be led by
team Client's Tech Lead) Act as liaison to other project functions
and maintain alignment across team memberso Includes working with
Client OEMs and CMs, which will include correspondence and
oversight of their C&Q process Understand concepts and
processes involved to design and deliver GMP equipment Provide
monthly roll-up outlining current month accomplishments, next month
plans, scope changes, financials (baseline, forecast, actual, and
project budget), staffing plan (baseline, forecast, and actual) and
issues/risks.Requirementso Bachelor of Science degree in
Engineering or Comparable Technical fieldo Minimum of three (3)
years Commissioning, Qualification, and/or Validation experience
within technical/regulated industrieso 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.)o
Knowledge of industry CSV and C&Q expectations and requirements
(e.g. FDA guidelines, USP, GAMP 5, ISO, etc.)o Excellent critical
thinking and problem-solving skillso Ability to prioritize a wide
range of workload with concurrent critical deadlineso Desire to
grow professionally with PACIV-NC project team and through ongoing
training opportunitiesPreferred Qualifications:o Knowledge and
experience with cloud-based document approval, execution, and
retention system, specifically eCQ KNEAT o Works well with others,
within a team and takes accountabilityo Can handle a high-pressure,
high-stress work environmento Result driven and self-motivatedo
Strong interpersonal and communication skills (verbal and
presentation)o Organized, with strong computer literacy such as MS
Project, Excel, etc.Other Requirementso Location: North Carolinao
Standard Day Shift ( 8 am - 5 pm or similar is expected)o Travel:
Up to 15% for the following: Onsite FAT and SAT execution
supporting OEM and CM locations (may be Domestic-based or
International Travel) Various trainings, conferences or meetings
with vendors, suppliers, etc.CompensationCompetitive Salary and
Benefits Package, which includes:o Paid Time Off (PTO) for
vacation, sick, and company holidays PTO is earned on an accrual
basis throughout the calendar yearo Health Insurance PACIV pays 90%
of the premium for the health insurance plan. Monthly contributions
made by PACIV and are distributed through an HSA (Health Savings
Account)o $25,000 Basic Life Insurance Plan for all full-time
employees, with additional plan options offered at the employee's
costo 401(k) Retirement Plan with company matcho Project
Performance Bonuses (for qualified projects and employees)Job Type:
Full-timePay: From $70,000.00 per yearExperience level: 3
yearsSchedule: 8 hour shift Monday to Friday Weekend
availabilityAbility to commute/relocate: Concord, NC: Reliably
commute or planning to relocate before starting work
(Required)Education: Bachelor's (Required)Experience: C&Q and
Validation: 3 years (Required)Work Location: One location
Keywords: PACIV-USA, LLC, Charlotte , Validation Engineer, Engineering , Concord, North Carolina
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