Manager, Process Engineer Details

Manager, Process Engineer

Emergent Biosolutions - Canton, MA

Employment Type : Full-Time

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.
JOB SUMMARY
The Manager, Process Engineer is responsible for leading the engineering team for cGMP facility and process equipment design, scale-up, specifications, installations, commissioning, and technical support. This position reports directly to the Deputy Director, Engineering.

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

• Engineering oversight of cGMP clean utilities and process equipment, including design, scale-up, specifications, installations, commissioning, and technical support
• Manage employees, contractors, and vendors related to new process equipment, and utilities
• Perform cost analysis to support new programs, scale-up proposals, and upgrades to existing systems
• Develop best practices, routines and innovative solutions to improve process and quality of output
• Perform risk assessment, incident investigation and corrective actions
• Provide process documentation and operating instructions
• Provide technical support to process development and production teams
• Vision to guide a team in engineering requirements when developing new systems
• Manage and improve process for creation and control of approved CAD drawings to define process equipment, utilities and facilities

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.

MINIMUM EDUCATION, EXPERIENCE, SKILLS

• Bachelor’s degree required; degree in engineering preferred
• Minimum of 8 years' relevant industry experience of which 4 years as a process engineer and 4 years in the process development, cGMP maintenance or validation in the biotech or pharmaceutical industry
• Minimum of two years of work experience supervising technical team.
• Proven work experience in a facility and process engineering
• Proven collaboration skills, learning agility, conceptual and strategic thinking, passion for results, and ability to navigate ambiguity
• Knowledge in design cGMP manufacturing facility
• Knowledge in FDA and ISO guidelines
• Knowledge in AutoCAD
• Knowledge in FMEA, risk analysis, process characterization, and project management

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.