Process Equipment Engineer
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 Process Equipment Engineer is responsible to support the development of scope, design, client interface, cost and schedule development, project reporting, , procurement, start-up scheduling and execution, and managing validation interfaces on assigned capital projects for process equipment and other related projects as assigned. The Process Equipment Engineer serves as Subject Matter Expert in a specific technical area with responsibilities to train and support users, troubleshoot and resolve operational problems, and process improvement projects. This position takes supervisory direction but sets their day to day activities. This position is a full time, onsite position.
II. ESSENTIAL FUNCTIONS
[THE FOLLOWING SENTENCE MUST BE INCLUDED AT THE TOP OF THIS SECTION]: Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
• Demonstrates technical problem-solving skills related to complex project execution and site equipment / systems troubleshooting challenges for process equipment relevant to drug substance manufacturing .
• Must have hands on working knowledge of some or all of the following;
• Single Use systems (Bioreactors, Mixers, Chromatography, Tangential flow filtration (TFF), harvest/clarification)
• Stainless steel systems (buffer/media preparation, Clean-in-place (CIP), Steam in place (SIP)
• Participate as a team member in high performing cross-functional teams and timely execution of work assignments
• Must possess tactical capabilities in organizing required tasks in executing complex project work
• Must exhibit customer focus and effectively communicate with peer-level partners, user groups, senior management and clients.
• In depth working knowledge of cGMP requirements for biopharmaceutical manufacturing of Bulk Drug Substances.
• Must be compliant with processes, procedures, and instructions for all activities on assigned tasks.
• Participate in process equipment design, build, Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT) activities including the following.
• Develop Capital planning and Execution (CAPEX) for planned and unplanned process equipment needs
• Coordinating efforts with end users, clients and equipment fabricators
• Collaborate, review and comment on equipment documentation (Design documents, Site procedures (SOP’s), and validation protocols.
• Assisting with equipment integration to site network, other systems and site historian
• Planning site activities with vendors.Support the validation group during execution of Installation and Operational Qualification (IQ/OQ) activities.
• Provide assistance, including onsite support on off hours, nights, weekends and holidays as needed to support the manufacturing production activities.
• Supporting efforts for process equipment located within a cleanroom environment.
• Participate in daily huddle meetings as a representative for process equipment.
• Support site process improvement initiatives.
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
Education: Bachelor of Science degree in Engineering
Experience: 5+ years of experience preferably in the pharmaceutical industry and demonstrated experience leading selected technical scope on projects
Knowledge: In-depth working knowledge of GMP requirements, design and construction practices, construction safety, business processes, including project management. Expert knowledge of engineering principles and concepts in selected discipline.
Skills: Typical office computer software skills (email, spreadsheets, word documents); organization, record keeping, and planning skills; project management, time management
Abilities: able to translate strategy to action, Effective verbal and/or written communicate at all levels of organization, work effectively in ambiguous situations, ability to multi-task, proven track record of increasing customer base
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.
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.