Sr. Project Engineer

Description

Sr. Project Engineer

Salt Lake City, UT 

Competitive Salary & excellent benefits package

Responsibilities: 
•    Provides leadership in working with R&D, Planning, Marketing, Quality, and Global Business Category groups to ensure Salt Lake City plant cGMP/FDA operations can successfully meet needs of company and consumers
•    Designs and implements processing systems that comply with specified cGMP criteria, managing projects from start to finish including system validation.
•    Works with plant operations to ensure behaviors and on-going process improvements meet cGMP requirements with no negative consequence to quality
•    Assures compliance with all regulatory agencies and helps implement procedures and policies for on-going compliance and measurement
•    Manages interaction with governmental agencies and customers as necessary
•    Drives root cause analysis and failures with implementation of all corrective and preventative actions 
•    Proposes process design and layout to maximize operational efficiencies
•    Prepares Capital Expenditure Requests for new processing equipment, managing budget control for complete project. 
•    Coordinates the installation and start-up of new equipment with operators, contractors and vendors.  Revises engineering drawings to incorporate changes as appropriate and in compliance with cGMP protocol.
•    Prepares work specifications and negotiates contracts for work to be performed by outside contractors.  Coordinates/directs work of outside contractors to insure quality completion of project and adherence to all applicable codes, regulations, laws and plant policies including OSHA, EPA,FDA, and RB Contractor Management
•    Prepares and submits reports as required, such as proposed projects reports, current studies and investigations, validation reports, project status reports, project cost, project timelines, project folders.  Develops spreadsheets that define process capabilities.
•    Facilitates continuous improvement by evaluation of existing operations in light of new technology, team needs and cost/benefit opportunities.
•    Can perform IQ/OQ of equipment and infrastructure regarding OTC requirements.
•    Has experience with designing/troubleshooting building utilities. (HVAC, dehumidification, boilers, hot water systems).
•    Provide leadership/guidance/support to project engineers if needed technically.

Qualifications:

•    B.S. Engineering Discipline  
•    Minimum >5 years’ experience in leading capital projects preferably in OTC pharmaceutical environment.
•    Ability to develop, read, and understand PFD’s, P&ID’s, equipment sizing, conceptual designs, and optimal utility consumptions
•    Knowledge of cGMP and/or FDA regulatory compliance.
•    Working knowledge of CAD, Microsoft Office, Project Management Software
•    Excellent interpersonal and problems solving skills in dynamic environment where managing multiple priorities is the norm
•    Self starter and solid team player who is willing to challenge the status-quo
•    Committed to continuous improvement and learning

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Equality

All qualified applicants will receive consideration for employment without regard to age, disability or medical condition; colour, ethnicity, race, citizenship, and national origin; religion; pregnancy, family status and caring responsibilities; sexual orientation; sex, gender identity, gender expression, and transgender identity; protected veteran status; size or any other basis protected by appropriate law.