Sr. Manager, Project Engineering (32038_Gaithersburg)
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 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.
II. ESSENTIAL FUNCTIONS
Reasonable accommodations will be made to enable individuals with disabilities to perform the 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.
III. MINIMUM 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
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.
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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.