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Project Engineer - Pharmaceuticals

GMP PROS®

Project Engineer - Pharmaceuticals

Lincoln, NE
Full Time
Paid
  • Responsibilities

    WE'RE PROUD TO BE A GREAT PLACE TO WORK US-CERTIFIED™ COMPANY! #PHARMA #PHARMACEUTICALS #ENGINEERINGJOBS #SUPPYCHAINJOBS

    GMP PROS SEEKS PROJECT ENGINEER – PHARMACEUTICALS!  THIS POSITION REQUIRES 30-40% DOMESTIC AND INTERNATIONAL TRAVEL. 

    ***THIS POSITION REQUIRES PHARMACEUTICAL, ANIMAL HEALTH, OR MEDICAL DEVICE INDUSTRY EXPERIENCE. PLEASE DO NOT APPLY IF YOU DO NOT HAVE EXPERIENCE IN THESE INDUSTRIES. ****

    BE PART OF AN EXCITING “START-UP” THAT SUPPORTS THE WORLD'S LEADING PHARMACEUTICAL AND ANIMAL HEALTH COMPANIES. ATTAIN THE BEST OF BOTH WORLDS. GAIN EXPERIENCE LEADING PROJECTS FOR A GLOBAL COMPANY WHILE ENJOYING THE FLEXIBILITY, ENERGY, AND PERSONAL ATTENTION THAT CAN ONLY BE FOUND WORKING IN A SMALL, CLOSE-KNIT COMPANY.

    BENEFITS

    Includes killer benefits: 401k with a 10% company match with no requirement to match and immediate vesting, flex time off, healthcare, dental, vision, life, AD&D, competitive compensation with a quarterly “additional comp” opportunity, paid floating holidays, and paid time off.

    • ARE YOU A PROACTIVE DOER?
    • DO YOU NEED VARIETY AND CHANGE TO KEEP FROM GETTING BORED?
    • DO YOU BUILD RELATIONSHIPS EASILY AND ARE YOU ABLE TO COMMUNICATE INFORMATION SO THAT IT IS EASILY UNDERSTANDABLE?
    • DO YOU LIKE WORKING IN A TEAM SUPPORTIVE ENVIRONMENT WHERE OTHERS WANT TO HELP YOU SUCCEED?
    • DO YOU TRY TO FIND A BETTER WAY FOR EVERYTHING BECAUSE THAT IS THE WAY IT SHOULD BE?
    • DO YOU THRIVE IN ORGANIZED CHAOS AND HIGH-PRESSURE SITUATIONS?
    • DO YOU QUICKLY BECOME AN EXPERT IN ANY SUBJECT MATTER YOU ARE WORKING IN?
    • CAN YOU STAY MOTIVATED AND HELP MOTIVATE OTHERS IN THE FACE OF ADVERSITY AND CHANGE? ARE YOU RESILIENT?

    THE ESSENTIAL DUTIES:

    THIS POSITION REQUIRES PHARMACEUTICAL, ANIMAL HEALTH, OR MEDICAL DEVICE INDUSTRY EXPERIENCE. PLEASE DO NOT APPLY IF YOU DO NOT HAVE EXPERIENCE IN THESE INDUSTRIES.*

    • Plans and directly manages complex cross functional equipment and facility projects that may include internal and external resources and contracted companies.
    • Works closely with engineering functional management, and other functions to gain resource commitments and resolve issues.
    • Formulates and gains approval for overall project plan in consultation with senior management and stakeholders.
    • Monitors progress to plan and implement corrective actions or contingencies as needed to maintain commitments.
    • Provides management with regular project status, variances to plan, and identification of corrective actions.
    • Coordinates between projects, maximizes synergies, and helps resolve resource conflicts.
    • Reviews and redlines engineering drawings including manufacturing and packaging equipment, facility layouts, utilities, etc.
    • Manages installation and set-up of equipment used to manufacture or package a product.
    • Develops User Requirement Specifications

    HERE ARE THE REQUIREMENTS FOR THE SKILLED PROFESSIONALS WE ARE LOOKING FOR:

    • BS degree in a technical or engineering field, MS desirable. Electrical, Software, Mechanical, or Industrial engineering preferred.
    • At least 3+ years in a project management role, plus 2 years prior technical experience in an engineering or manufacturing engineering position.
    • Experience with both GxP pharmaceutical manufacturing and packaging is a plus.
    • Experience with managing GxP building infrastructure projects including demo and build out of manufacturing and packaging spaces.
    • PMP certification desirable.

    SOME OTHER THINGS THAT YOU WILL NEED TO BE SUCCESSFUL:

    • Excellent communication and organization skills, with an analytical and problem-solving mindset.
    • Ability to define problems, gather data, establish facts, and draw valid conclusions and recommendations.
    • Ability to multi-task and complete multiple projects on time.
    • Proven excellence in the use of project management tools and methodologies.
    • Proven record in process development and improvement.
    • Experience with different validation techniques and validating multiple processes at once.
    • Experience in manufacturing and/or bringing new products into production.
    • Experience with manufacturing of products in an environment employing ISO and FDA quality system regulations.
    • Responsible for performing all duties in compliance with FDA's Quality System Regulation (QSR), ISO13485, and all other international regulatory requirements.
    • Proven ability to lead teams and achieve challenging objectives with direct and indirect management of functional resources.

    PREFERRED QUALITIES AND TRAITS:

    • You must be driven to seek out new opportunities, ask questions, and keep pursuing things when information is limited or not given at all.  Be persistent!
    • Corrective actions require new thoughts and ideas on existing equipment or problems. Approach things with a broad scope at first and engineer solutions.
    • This is a tough position. You will have challenging project deadlines, budgets, and resource limitations. You will be in the trenches leading change and change will often be hard for your customers. It is a fantastic opportunity to gain experience and learn a wide variety of skills.  You will have challenges.  If you let things get to you it will show in your attitude towards others.  Having a positive approach will make others more willing to work with you and more willing to help you to achieve your goals.
    • In the fast-moving and changing industry of FDA regulated manufacturing, things will change continuously. You must be able to adapt to change and make forward progress.
    • You must be able to LISTEN to everyone's input before forming your thoughts or replies. Operators and others in the plant have a wealth of process and product knowledge. Some are limited to their specific trade so it's your job to take their information to the next level and fit it into the bigger puzzle.
    • You must be able to quickly turn information received into clear and concise verbiage on paper.  Always give the full context of events and detail actions to be taken.  Be careful not to use exaggerations in recalling events.
    • General knowledge of project timelines and cost is important, but don't let that limit you in the investigation and problem-solving phases.
    • You must be patient and focused while also having a continuous sense of urgency.
    • You will not always be right, and that is okay. There is a steep learning curve in this industry. Take in as much as possible and it will only benefit your future.

    PRE-EMPLOYMENT REQUIREMENTS:

    • Pass and maintain pre-employment background check.
    • Subject to motor vehicle report review.
    • Maintain valid driver's license and endorsements as required per position.
    • Pass pre-employment physical, medical evaluation, and drug screen due to the safety sensitive nature of this position.
    • Successfully complete and maintain any required safety certification and testing on an annual basis.

    NOTE: DIRECT APPLICANTS ONLY. WE ARE NOT ACCEPTING REFERRALS FROM THIRD-PARTY RECRUITERS.

    GMP Pros is an Equal Opportunity Employer. It is the policy of GMP Pros to provide equal opportunity in employment for all qualified individuals regardless of race, color, religion, ethnicity, national origin, ancestry, disability, medical condition, age, citizenship, sex, sexual orientation, gender, gender identity, gender expression, marital status, pregnancy, genetic information, military status, veteran status, and any other characteristic protected by law.

    This company participates in the United States Department of Homeland Security E-Verify program. The E-Verify program is an internet-based employment eligibility verification system operated by the U.S. Citizenship and Immigration Services. Please use the links provided for important information when applying for work with this company: E-Verify English / Spanish