Posted on: May 3, 2021
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Engineer is recognized as a strong technical contributor
within Workplace Services (WPS) supporting both GMP and Non-GMP
utilities and equipment required for the Frederick and Boulder
sites. This position will report to the Director of WPS (Work Place
Services) & EHS for Colorado.
You will manage certain
utilities at the site, including domestic water, HVAC, electricity,
and other supporting equipment and infrastructure. You will handle
all aspects of coordinating activities with other departments
including Manufacturing, Maintenance, Engineering, Quality
Assurance, Validation, Quality Control, etc. In addition, you may
also collaborate with customer personnel, auditors, and regulatory
authorities, as needed, to communicate system design,
qualification, and status of WPS maintained systems. This role
requires a significant amount of internal engagement with system
users and EHS function through strong interpersonal skills,
influence management and change management. You will implement and
ensure the execution of key initiatives against timeline and
deliverables, including identifying bottlenecks, resolving issues,
and driving towards effective and standardized
The Facility Engineer is an
individual contributor within the WPS/EHS team. A strong predictor
of success for this role is being able to be flexible and
multi-task while working on several project timelines independent
of each other. Must influence others through your knowledge of
regulations that support the facility, process, and safety needs.
Strong project management skills as demonstrated through
collaboration with multiple departments and external
partners/vendors are critical for you to maintain timelines and to
keep the facility activities on track.
Strong technical engineering
skills. Able to work within a multi-functional team, and excellent
interpersonal and team-building skills. You will handle maintaining
reliability with WPS maintained utilities to establish a culture of
continuous improvement and strengthen troubleshooting programs,
identify root cause, and make appropriate corrective actions at our
Colorado manufacturing sites.
Qualifications and Knowledge needed to be successful in this
- Strong business
- Support all activities
associated with the site's utilities, including but not limited to,
operation, qualification, preventative maintenance, change control,
shut-down activities, risk assessments, leading investigations,
troubleshooting, root cause analysis and CAPA
- Ensure that all planned and
unplanned work is prioritized and managed closely to minimize
equipment downtime and disruptions to the manufacturing schedule.
Clear, concise, and timely communications regarding these
activities to all relevant partners (i.e.-manufacturing, quality
assurance, engineering/process maintenance, leadership,
- Maintenance of quality systems
and cGMP compliance
- GMP Documentation: Responsible
for new and replacement equipment install and operational
validations. Support validation of the facility with proper GMP
documentation. Additionally, support the facility design and
changes with CAPA, Change Controls, Deviations, etc.
- Developing Compliant Systems:
Develop and maintain standard operating procedures and other
procedures for systems to support the facility. Design, support.
maintain and comply with engineering standards, P&IDs, project
controls that allow for WPS to operate successfully.
- Ability to understand
regulatory requirements such as ICH Q7, 21CFR Part 210 and 211,
21CFR Part 600, and EMA guidelines as they relate to utilities and
- Supports equipment
commissioning, qualification and validation activities related to
systems owned by WPS.
- Experience with BAS
- Experience with CAD and MS
- Write, review and/or assist in
the development of SOPs in a timely manner.
- Identification, recommendation,
and implementation of replacement-in-kind, new or improved
equipment and/or systems in support of existing utilities as well
as new or existing manufacturing processes.
- Inspect and review projects to
monitor compliance with building and safety codes, and site
- Ability to read and interpret
P&IDs, equipment manuals and electrical/mechanical
- Work with other disciplines to
ensure the necessary details related to the systems are fully
coordinated, understood, and scheduled.
- Research equipment providers
and make recommendations and selections based on project
requirements and business needs.
- Drive continuous improvement to
support customer and regulatory expectations. Support and
participation in client and regulatory audits.
- Ability to build, lead and
motivate teams of employees and strategic outsource
- Highly skilled at influencing
major clients and partners through strong relationships, expertise,
- Strong problem-solving and
- Ability to produce and deliver
executive-level presentations; strong executive presence; ability
to read audiences and adapt communication style and delivery of
- Ability to quickly develop a
thorough understanding of all areas of the organization and of the
organization's key functional processes and resources.
- Ability to make, own, and
communicate hard decisions.
- Able to operate and collaborate
within a matrix organization.
- Good balance of strategic and
- Navigate ambiguity and deal
with constant change and take measured risks.
Keywords: Agilent, Boulder , Facility Engineer, Other , Boulder, Colorado
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