Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Office
Job Description
Carries out management of engineering projects including estimating costs, sourcing, identifying, specifying, purchasing and installing equipment, design/modification of existing or new GMP facilities, commissioning and qualification of equipment, utilities and facilities.
A day in the life:
Monitors progress and assures all capital projects are being completed in scope, on time, and within budget.
Develops and presents recommended project solutions along with realistic cost estimates to internal clients. Makes appropriate changes to the scope and communicates these changes to key customers.
Develops, reviews, and understands engineering drawings including P&IDs, E/P plans, and overall equipment layouts. Specifies facility/utility requirements associated with each piece of equipment.
Develops, reviews & performs Installation Qualification (IQ)/Operational Qualification (OQ)/Performance Qualification (PQ) protocols and change control documentation.
Continually leads all aspects of the contractors' safety performance and promptly resolves any safety violations that occur.
Drives the process of installing and commissioning equipment and/or modifying facilities to meet site customer and company client requirements with minimal interruption to operational schedules, ensuring good engineering practices are adhered to for the construction, installation and commissioning of new processes and facilities.
Education:
Bachelor's degree in Mechanical, Chemical, Electrical, Industrial Engineering or related subject area is required
Experience:
1 year of previous related experience and general knowledge of a pharmaceutical manufacturing environment is preferred
Knowledge, Skills, and Abilities:
REQUIRED:
Proficiency using Microsoft Office applications including Project.
Excellent judgment, decision making and trouble shooting skills.
Self-starter with an ability to work in a fast-paced environment.
Dedication to our fundamental principles of Integrity, Respect and Excellence
Proficiency with the English language
PREFERRED:
Strong verbal and written communication skills to collaborate to achieve team goals and expectations.
Strong time management skills.
Familiarity with Good Manufacturing Practices (GMPs)