CQV, Engineer I
Company: IPS-Integrated Project Services, LLC
Posted on: March 17, 2023
Performs cGMP compliance-based services (commissioning,
qualification, validation, consulting, etc.) as developed and
defined in project agreements with IPS' clients. Follows IPS and
client standards and requirements, overall good industry practices
for C/Q/V services and regulatory requirements. May also perform
standalone commissioning services for non-FDA regulated
KEY ACTIVITIES AND RESPONSIBILITIES
- Write C/Q/V documents following established standards and
templates, including but not limited to the following:
- Commissioning Forms
- C/Q/V Protocols and Summary Reports
- Standard Operating Procedures
- Impact Assessments
- Specifications (URS/FRS/DDS)
- Perform field/site activities including, but not limited to,
- Attend and witness FATs and SATs as a representative of IPS
- Execution of commissioning forms and witnessing of vendor
start-up and testing.
- Execution of C/Q/V protocols.
- Walkdown and verification of system drawings (P&IDs,
- Compile data and prepare reports for completed C/Q/V activities
including ETOPs, protocol data packages, etc.
- Assist in deviation investigation and resolution of problems
and issues encountered during field execution activities.
- Work with the Project Delivery department or CM for start-up
and vendor testing. Witness and troubleshoot as required.
- Primary responsibilities include C/Q/V of equipment and
systems, including CSV and automation, supporting pharmaceutical,
biotech, and medical device industries.
- Read, understand and utilize the IPS Best Practices and SOPs
for delivery of compliance services
- Perform work to meet IPS budget requirements and quality
standards. Provide consistent, complete, and timely feedback and
reports to IPS project leaders, project managers, or management, of
project status and issues, as requested.
- Other duties as assigned.
Qualifications & Requirements
REQUIRED EDUCATION/QUALIFICATIONS /WORK EXPERIENCE
- Bachelor of Science in Engineering.
- Entry level position. 0 to 2 years of relevant
- Experience in Pharmaceutical, Biotech, Medical Device Design,
Construction, Commissioning, Validation, or QA. Experience in
writing and execution of PFC, FC, IQ, OQ, and PQ forms/protocols
for GMP Utilities, Equipment, Systems, and Software a
- General exposure and experience in a GMP/Validation discipline
with a knowledge and understanding of pharmaceutical
Design/Build/Commission/Validate processes and how they relate to
regulatory requirements and cGMP regulations within the E.U. and
U.S. FDA helpful.
CONTEXT AND ENVIRONMENT AND SAFETY
- This position will have up to 100% travel, or as required by
the assigned project. Position may be assigned to client site for
an extended period of time. Overnight travel or staying in the city
of Client's location is possible depending on assignment. Travel
will be per the IPS Travel Policy, client specific travel policy or
project specific travel plan. Position will visit Client sites and
will be required to adhere to stated safety rules. Position may
visit active construction sights and will be required to take site
safety training and adhere to site safety rules.
- This position is a safety sensitive position. The employee is
designated for field work and attends activities at client sites
where they work in construction, process, packaging, manufacturing,
research or other "non-administrative" areas.
- Proficiency with Microsoft Office applications (Word, Excel,
Project, Powerpoint, etc).
- Personal skills and traits include:
- Sense of urgency
- Team player
- Able to multi-task
- Effective time management
- Able to effectively prioritize
- Good interpersonal skills
- Attention to detail
- Excellent customer service skills
- Leads by example. Deems the respect of upper management, peers
and subordinates. Empowers staff to succeed.
- Supports and deploys technical training programs that assure
competency and advancement levels to support corporate
- Promotes a friendly and efficient work environment, which
rewards achievement and recognizes teamwork and champion's
technical advancement, which supports our corporate goals.Maintain
professional conduct and deliver services in a professional and
- Works in conjunction with department management in recruiting
new staff members and promoting IPS to potential hires (focused on
cleaning and process validation).
Core Value Candidate Qualifications
- Must exhibit an entrepreneurial spirit by consistently seeking
new opportunities to add value to the organization. Must strive for
excellence in all aspects of job performance. -Must approach their
work enthusiastically with a contagious energy and drive that shows
everyone they love what they do.
- Must display creativity and innovation by continually working
to improve solutions, tools, methods and service delivery
- Must conduct oneself with an uncompromising commitment to the
welfare of our clients and each other. Must act in an ethical,
professional and respectful manner at all times.
- Must exhibit the ability to build and sustain long term
relationships of mutual value through teamwork.
- Must be driven to succeed and committed to goal attainment.
IPS-Integrated Project Services is a global leader in developing
innovative and cost effective solutions for the engineering,
construction, commissioning and qualification of complex
pharmaceutical and biotech research and manufacturing facilities.
With technical expertise spanning R&D to pilot-scale to
large-scale production, our team specializes in the technology,
trends and regulatory environment to successfully deliver capital
projects and improve operations. For over thirty years, we have
applied unique LEAN methodologies throughout the project life
cycle, continually finding ways to do things better and more
efficiently, delivering higher quality and controlling costs.
Headquartered in Blue Bell, PA, IPS is a multi-national company
with over 1,500 professionals worldwide and offices in California,
Kansas, Maryland, Massachusetts, New Jersey, North Carolina,
Pennsylvania, Brazil, Canada, China, Ireland, Singapore,
Switzerland, Germany, United Kingdom and four locations in India.
Visit our website at www.ipsdb.com.
Process Architecture, Process Design, Engineering, Construction,
Commissioning, Qualification, LEAN Project Delivery, Strategic
Master Planning, Energy Conservation Management, Project Controls,
Program/Project Management, Operations/Logistics Strategy and
Planning, EPCMV and Staffing Services.
IPS is an equal opportunity, affirmative action employer of
protected veterans (M/F/D/V).
Attention Search Firms / Third Party Recruiters: IPS is not seeking
assistance or accepting unsolicited resumes from search firms for
employment opportunities with IPS. Regardless of past practice, all
resumes submitted by search firms to any employee at IPS via-email,
the Internet or directly to hiring managers at IPS in any form
without a valid written search agreement in place for a specific
position will be deemed the sole property of IPS, and no fee will
be paid in the event a candidate is hired by IPS as a result of the
referral or through other means.
Keywords: IPS-Integrated Project Services, LLC, Cary , CQV, Engineer I, Engineering , Morrisville, North Carolina
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