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.
- JOB SUMMARY
Responsible for designing, developing, managing, and/or maintaining equipment which is used to monitor and control engineering systems, machinery, and processes. Also responsible for the interface between the hardware and software development for the automation system. 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.
- Responsible for requirements gathering, design, configuration, integration and implementation of process control solutions for the manufacturing industry including batch software, PLC / DCS systems, HMI packages, SCADA systems, Visual Basic and PC networking technology
- Possesses strong knowledge of computer system validation and related practices, including governmental regulations. Developing broader skills and applies this knowledge and skills to perform a variety of standard activities
- Preparation of design packages and specification, functional specifications related to software and hardware RFPs, design review, vendor/contractor selection, constructability reviews, approval of submittals, and preparation and oversight of validation and regulatory submissions
- Preparation of engineering standards, approval of submittals, and authoring PMs, SOPs, Commissioning Protocols, and conducting training for new equipment installations
- Author, review, and approve automation system lifecycle design documentation (user requirements, functional and design specifications, commissioning, and qualification protocols)
- Act as a coach and mentor to 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.
- Has wide-ranging experience, using professional concepts and company objectives to resolve complex issues in more efficient ways than lower levels.
- Work on complex issues where analysis of situations/data require in-depth evaluation of variable, identified factors.
- Exercises judgment normally in selecting methods, techniques, and evaluation criteria in resolving issues.
- Determines own instructions and procedures on day-to-day tasks and 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.
III. MINIMUM EDUCATION, EXPERIENCE, SKILLS
- A minimum of 8 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
- EE or Computer Science preferred
- 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
- Strong knowledge of engineering and related practices, including governmental regulations – ISPE GAMP, EU Annex 11, CFR 210, 211, Part 11
- Proven programming experience with either of the following industrial automation systems: Allen-Bradley PLCs or Emerson DeltaV DCS
- Must have knowledge of process manufacturing field instrumentation, technology, and batch process manufacturing expertise
- Experience in all phases of the automation life cycle: Requirements documentation, detailed design generation, implementation, system integration, testing, on-site startup and ongoing system maintenance
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.