BioSpace – Limerick, County Limerick, Ireland
Within this role you'll be responsible for designing, specifying and commissioning new and renovated biopharmaceutical process equipment, providing engineering support and problem solving for existing equipment and manufacturing processes.
Typical day
Managing the scope, deliverables, scheduling, budgeting and quality of engineering projects related to cGMP process equipment, piping, controls and facility
Assisting in the design review, site acceptance and installation of equipment
Preparing and presenting project status reports
Preparing, presenting, and disseminating technical information relating to equipment, engineering and GMPs
Recommending and managing implementations of appropriate corrective/preventative actions for existing equipment and manufacturing processes
Assisting in development of departmental policies, procedures and specifications
Acting as a Subject Matter Expert during regulatory inspections and internal investigations
Supporting the QA Validation department by preparation of design documents and assisting in protocol execution
Assisting in investigations of process equipment, utility systems, and control system anomalies, as well as safety incidents
Preparing engineering evaluations and test plans for and executing change control documentation
May supervise mechanical, electrical, and automation contractors
Maintaining a clean and safe working environment by enforcing procedures, policies, and regulations
Maintaining company reputation by enforcing compliance with all relevant laws, policies and regulations
This role may be for you if
You enjoy and have a strong background with working on projects
You possess excellent communication, negotiation, and stakeholder management skills
You have the ability to think strategically and execute tactically in a fast-paced environment
You are able to prioritise and re-prioritise as needed and adapt to change
To be considered for this opportunity you should have a BS/BEng in Chemical, Process or Mechanical engineering with 8+ years related experience. Direct experience with biopharmaceutical process equipment is preferred. May substitute relevant experience for education.
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company’s business.
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