We go where others won’t, taking on some of the biggest public health challenges to protect and enhance millions of lives, and create a better, more secure world. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect and enhance life.
Responsible for oversight of design, installation and ongoing troubleshooting of process equipment systems, controls and procedures used in pharmaceutical biologics manufacturing. Perform and oversee field engineering work to ensure quality, troubleshoot problems and drive results. Provide professional assistance and technical advice to support ongoing operations/manufacturing investigations through data analysis and team based problem solving methodologies.
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
• Develop preliminary engineering drawings such as layouts, P&IDs and PFDs
• Prepare or review engineering calculations for analysis related to process design and equipment selection
• Act as project technical lead on highly complex projects, responsible for some project coordination activities
• Provide process engineering support in deviation investigations, CAPAs, and change controls
• Analyze process data to support investigations and identify process improvements.
• Lead process risk assessments by applying standard project risk techniques and developing risk response plans with project team and stakeholders
• Lead procurement and vendor/contractor selection, constructability reviews, approval of submittals, field execution, commissioning protocol development and execution, and oversight and review of validation plan and regulatory submission strategy
• Influence other members of the Project Engineering and SME’s on project teams to drive continuous improvement, knowledge transfer, and professional growth of both you and your colleagues
• Identify areas to drive down project costs through lessons learned and develop specific improvement strategies to realize these savings.
• Experienced professional with full understanding of work; resolves a wide range of issues in creative ways.
• Work on problems of increasingly diverse scope; analysis of situation/data requires evaluation of identifiable factors.
• Demonstrates good judgment in selecting methods and techniques for resolving issues and obtaining solutions.
• Receives little instruction from supervisors, general instructions on new assignments.
• Drive the complete execution of assigned projects in manner that drives high engagement from project team members.
The above statements are intended to describe the general nature of work performed by those in this job. It is not an exhaustive list of all duties, and other duties may be assigned.
MINIMUM EDUCATION, EXPERIENCE, SKILLS
• A minimum of 5 years of experience in a biopharmaceutical or related environment in a project or construction management related role
• BS in Engineering, Science, Project/Program Management or equivalent experience
• Technology/Equipment (DP/DS/Clinical/Commercial/SS/SU) emphasis will vary by site, candidate is expected to be able to guide site to top quartile operational safety, efficiency, and reliability for these technologies.
• Ability to think and act both strategically and tactically
• Highly effective verbal and written communicator at all levels of the organization
• Demonstrated ability to effectively prioritize and coordinate activities
• Proficiency in Microsoft Office applications
• OTJ experience with process design requirements for a pharmaceutical, biotech, or food industry (ISPE Baseline Guides, ISO and ASME BPE, EU/FDA Regulations for biological and drug products)
• Understanding of generation and distribution of high purity systems such as Water of Injection, CIP, Sterilization processes, Clean Steam, Clean Compressed Air
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.
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.