Sr. Manager, Project Engineering
Company: Emergent Biosolutions
Location: Rockville
Posted on: January 20, 2023
Job Description:
Those who join Emergent BioSolutions feel a sense of ownership
about their future. You will excel in an environment characterized
by respect, innovation and growth opportunities. Here, you will
join passionate professionals who advance their scientific,
technical and professional skills to develop products designed-to
protect life.
JOB SUMMARY
- The Sr. Project Engineering Manager will be responsible for
supervision of project engineering staff and leadership for all
project engineering systems at Rockville (including facility and
equipment design, installation, start-up and
commissioning).
- This role serves as the Chair for the site capital committee
and management of the site's capital program.
- This individual will need to manage multiple projects of
varying complexity and size which will include outside consultants
and contractors and guidance of Emergent engineers, technicians,
infrastructure, manufacturing personnel, validation personnel, and
quality control/quality assurance.
- They will provide leadership for the conceptual and detailed
engineering design efforts pertaining to capital projects at
Rockville.
ESSENTIAL FUNCTIONS
- Supervision of the site's project engineering functions
including personnel, establishing project engineering standards, ,
and departmental and individual performance goals to match annual
site Hoshin goals.
- Management of the site capital program to ensure compliance
with global standards and the site/local charter for site capital
planning, delivery, and reporting.
- Responsible for planning, scheduling, conducting, and
coordinating the management of projects. Preparation of design
packages specifications, request for proposals, design review,
vendor/contractor selection, constructability reviews, approval of
submittals, project budgets, schedules, preparation and oversight
of validation and commissioning
- Interfacing with Procurement to develop and/or maintain uniform
and cost effective contracting practices for construction
services
- Complete reporting requirements to meet the Integrated
Financial Planning process
- Seek cost savings for on-going operations and capital projects.
For example, tax incentives and special government
programs,
- Interfacing with Procurement and Legal to develop and/or
maintain uniform and cost effective contracting practices for
construction services
- Preparation of design packages and specifications, functional
specifications related to engineering, construction, and equipment
procurement RFPs, design review, vendor/contractor selection,
constructability reviews, approval of submittals, and preparation
and oversight of validation and regulatory submission
- Develops and monitors project budgets and schedules for
compliance to plans
- Coordinates the efforts of engineering support groups and
external resources such as vendors, consultants, and
contractors
- Preparation of engineering standards, approval of submittals,
and authoring PMs, SOPs, Commissioning Protocols, and conducting
training for new equipment installations
- Support project technical lead on highly complex projects and
will be responsible for project management activities. May serve as
project technical lead for complex projects
- Requires vaccination against different viruses including
Vaccinia virus.
- Interface with local permitting agencies
- Responsible for maintaining a safe work environment
The above statements are intended to describe the nature of work
performed by those in this job and are not an exhaustive list of
all duties. Nothing in this job description restricts managements
right to assign or reassign duties and responsibilities to this job
at any time which reflects management's assignment of essential
functions.
EDUCATION, EXPERIENCE & SKILLS
- Bachelor's degree in Engineering from an accredited university
in mechanical, chemical, or electrical disciplines
- Minimum of 15 years of industry experience managing capital
projects and programs
- Minimum 10 years engineering experience in a pharmaceutical
industry setting with a focus on aseptic processing
- Must have knowledge of clean utility and manufacturing facility
and infrastructure expertise in all the following project phases:
Requirements documentation, detailed design generation,
implementation, system integration, testing, qualification, and
on-site startup
- Strong communication and computer skills
- Responsible for working well within teams and be effective in
leading teams and meetings with the customer, other project
stakeholders, and external consultants during all phases of the
project
- Must be able to provide clear direction while motivating
teams
- Must lead by example through strong work ethics and high
standards
- Desire to continue to promote personal development and
development of direct reports
- Exercises judgement within broadly defined practices and
policies in selecting methods, techniques, and evaluation criteria
for obtaining results.
- Responsible for demonstrating skills gathering, design,
configuration, integration, and implementation of engineering
solutions Preferred Requirements
- Advanced degree in an engineering discipline
- Member of PMI, ISPE, ASME, AICHE, or IEEE
- Familiar with pharmaceutical industry guidelines such as ISPE
Baseline Guidelines, and BPE Standards
- Experience in aseptic processes for pharmaceutical,
biopharmaceutical, or consumer manufacturing
- Knowledge of CAD software and equipment
- Working knowledge of SAP
- Familiarity with FDA cGMP and FDA regulations relating to
biologic and drug products
Per CDC guidelines, Emergent strongly recommends that all employees
working on site are vaccinated to help ensure their safety, as well
as the safety of fellow employees. This includes the use of good
judgment when determining when the CDC guidelines advise that you
stay home when ill.
There are physical/mental demands and work environment
characteristics that must be met by an individual to successfully
perform the essential functions of the job. This information is
available upon request from the candidate.
Reasonable accommodations may be made to enable individuals with
disabilities to perform all essential functions.
Emergent BioSolutions is an Equal Opportunity/Affirmative Action
Employer and values the diversity of our workforce. Emergent does
not discriminate on the basis of race, color, creed, religion, sex
or gender (including pregnancy, childbirth, and related medical
conditions), gender identity or gender expression (including
transgender status), sexual orientation, age, national origin,
ancestry, citizenship status, marital status, physical or mental
disability, military service or veteran status, genetic information
or any other characteristics protected by applicable federal, state
or local law.
Information submitted will be used by Emergent BioSolutions for
activities related to your prospective employment. Emergent
BioSolutions respects your privacy and any use of the information
submitted will be subject to the terms of our .
Emergent BioSolutions does not accept non-solicited resumes or
candidate submittals from search/recruiting agencies not already on
Emergent BioSolutions' approved agency list. Unsolicited resumes or
candidate information submitted to Emergent BioSolutions by
search/recruiting agencies not already on Emergent BioSolutions'
approved agency list shall become the property of Emergent
BioSolutions and if the candidate is subsequently hired by Emergent
BioSolutions, Emergent BioSolutions shall not owe any fee to the
submitting agency.
Keywords: Emergent Biosolutions, Rockville , Sr. Manager, Project Engineering, Executive , Rockville, Maryland
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