Job details
Job type full-time
Full job description
Thermo fisher scientific incIs the world leader in serving science, with annual revenue exceeding $25 billionOur mission is to enable our customers to make the world healthier, cleaner and saferWhether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them.
This role is based in the greater boston area – seated remotely in the interim, ultimately seated in one of vvs’ commercial facilities in cambridge, lexington, or plainvilleOccasional travel to alachua, fl and other local facilities may be required.
Thermo fisher scientific - viral vector services (vvs) is a rapidly growing, dynamic gene therapy contract development and manufacturing organization (cdmo) that is seeking sharp individuals to bring the highest quality processes, products and testing to our clientsOur employees are committed to making a difference in our organization, for our client partners and the patients we serveWe are looking for top talent with proven competencies and strong character to join our team and help lead our organization into the future.
How will you make an impact?
The staff mes engineer will be a member of the viral vector services global engineering teamThe staff engineer is responsible for providing advanced level expertise to global engineering digital projects including feasibility & concept studies, capital facility buildouts and new systems implementations, process improvement projects, etcHe/she may serve as the overall project lead or project technical leadThe role requires the ability to manage multiple contractors and a portfolio of technical projects at the same timeThe staff engineer will provide technical leadership, guidance, and support to the operations teams at each vvs site as needed and will partner with the various functions to develop technical roadmaps and capital investment strategiesThe staff engineer will be responsible for developing, deploying, and maintaining the good engineering practices (gep) program at vvs for the creation of technical engineering standards(s)he creates and maintains relationships with other vvs sites to develop and promote engineering best practices and ensures compliance with vvs sop’s, safe work practices, and cgmp regulationsThe position involves close collaboration with manufacturing, manufacturing sciences, automation, quality assurance, quality control, and global and site engineering teams to complete all responsibilities.
What will you do?
Lead the implementation of mes at different vvs sites which includes the development of equipment tracking workflows, weigh and dispense sap interfaces, and electronic batch records.
Act as a global mes system owner and provide guidance to sites on new installations, upgrades, life cycle management, and day-to-day support.
Work with the site facilities & engineering leadership and the global engineering team to plan and manage operational budgets and capital investments.
Lead responses to digital systems related issues during production.
Create and maintain relationships with other vvs sites to develop and promote engineering best practices and ensures compliance with vvs sop’s, safe work practices, and cgmp regulationsThe position involves close collaboration with manufacturing, manufacturing sciences, quality assurance, quality control, and other engineering teams to complete all responsibilities.
How will you get here?
Education
Bachelor’s degree in engineering, science, or related field, with evidence of operational, leadership, or professional experience.
Experience
5+ years of experience in process development, operations or engineering in the biologics manufacturing industry
Hands on experience with mes systemsRockwell pharmasuite experience preferred.
Experience with project management
Experience with digital, automation, and business systems including but not limited to osi pi, sap, and deltav.
Experience with biologics drug substance and/or drug product manufacturing
Knowledge, skills, abilities
In depth understanding of general cgmp standards and practices
Candidate must have the capability to define and set technical direction for mes systems
Candidate must also have the capability to define user requirements in support of designing or procuring manufacturing execution systems.
Strong understanding of applicable regulatory requirements.
Strong technical documentation review and revision experience
Strong interpersonal and communications skills; written and oral
Ability to set goals and direction for others
Comfortable supporting concurrent issues
Working with both hands-on and remote based staff
High ethical standards to support a professional business code of conduct
Our global team of more than 90,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including thermo scientific, applied biosystems, invitrogen, fisher scientific, unity lab services and patheonFor more information, please visit www.thermofisher.com.
Thermo fisher scientific is an eeo/affirmative action employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
