Additional Job Listings

• Location:Chicago
• State:IL
• Salary:$170K+
• 

Job Types:

Biotech, Pharma, Med. Device R&D

Director of Engineering

Summary:

Responsible for developing and managing all engineering functions in an FDA regulated cGMP pharmaceutical manufacturing environment.  Includes comprehensive management of the current green-field plant design and build activities, expansion of offices and laboratory space, procurement of equipment for current and future needs, oversight of plant commissioning and validation activities, hiring and development of staff and troubleshooting and optimization of processes.

Essential Duties:

• Manage and direct the activities of the Engineering Department.


• Prioritizes and guides engineering resources in the design of new or improvement / expansion of existing manufacturing processes to deliver FDA compliant production capacity on time and within budget according to business plan.


• Guide the specification and selection of manufacturing equipment/utility equipment and reward architectural and engineering contracts based on comparative bids and analysis.


• Provide adequate workspace for all functions on-site through space planning for offices, laboratories and manufacturing areas.


• Plan and manage capital plan for facility and production equipment related spending to assure production is in a position to meet new product development and product launch manufacturing requirements.


• Assure plant preventive maintenance, metrology, facility cleaning, security, safety, industrial hygiene and environmental protection programs are functioning effectively and meet regulatory and outside agency compliance requirements.


• Leads projects such as; new equipment design and procurement, technology transfer, process optimization and scale-up, process and cleaning validations.


• Establish and develop an FDA compliant Engineering Documentation system.


• Development and supervision of direct reports.

Minimum Qualifications:

• BS in engineering or relevant technical discipline


• 10 years of experience in pharmaceutical engineering and validation related functions


• Experience managing plant design, construction, commissioning and validation projects


• Hands on experience in validation, equipment troubleshooting and repair


• Excellent knowledge of validation principles including commissioning, IQ/OQ/PQs, Process validation, Cleaning validation and Computer Related Systems validation


• Excellent working knowledge of cGMPs, OSHA compliance, HVAC systems and cleanrooms, and pharmaceutical processing and plant equipment


• Excellent technical writing, communication and organizational skills


• Experienced in financial and accounting principles/spreadsheets and Project Management


• Good interpersonal skills and the ability to work well in a team environment

Benefits

We offer fabulous potential for motivated professionals, great compensation, and full benefits including bonus, relocation assistance, dental insurance, medical insurance, and life insurance.  Pre-employment drug screening required. 

Your personal privacy and confidentiality are guaranteed.

Our firm is currently recruiting for several junior, mid, and senior level Engineering positions throughout the US.  If your qualifications do not meet the specified requirements for this position; but, you do have Engineering experience in food, beverage, biotechnology or CPG manufacturing, send a resume to the e-mail in connected to this posting and include a cover letter stating your career and relocation parameters.

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