1+ months

Sr. Manager, Project Engineering

Rockville, MD 20850


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.

I. 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 sites 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.
II. ESSENTIAL FUNCTIONS
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

Supervision of the sites 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 managements assignment of essential functions.
III. MINIMUM EDUCATION, EXPERIENCE, SKILLS
Bachelors 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 Privacy Policy<> .

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.

ABOUT EMERGENT

Protecting and Enhancing 1 billion lives by 2030 focuses our energy to improve the quality of life for individuals around the world, giving them the opportunity to experience the fullness of life.

Our drive towards this vision informs all of our actionswhether it is our approach to product development, manufacturing, encouraging employee health and wellness or giving back to the communitywe strive every day to achieve this shared goal.

WE BELIEVE IN OUR VALUES

  • Lead with Integrity
    • We gain trust and confidence through ethics, quality, and compliance excellence
  • Stand shoulder to shoulder no matter what
    • We combine our best thinking and communicate openly to support each other.
  • Own it always
    • Every person at Emergent is engaged and accountable for delivering on our commitments.
  • Break through thinking
    • We take smart risks, pursue innovation and challenge ourselves to constantly improve.
  • Compete where it counts
    • We set the right goals and respect each other as we conquer them together.

Categories

Industry

  • Biotechnology
Posted: 2021-11-15 Expires: 2022-12-04

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Sr. Manager, Project Engineering

Emergent BioSolutions Inc.
Rockville, MD 20850

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