Pharma Construction Project Engineer (Project Manager)

Leiters$95K — $115K *
Pharmaceuticals & Biotech
5 - 7 years of experience
Job Overview by Ladders

Qualifications

  • 5+ years experience in a cGMP FDA regulated pharmaceutical manufacturing environment; preference for aseptic processing facilities.
  • Understanding of cGMP guidelines and standards.
  • Bachelor's degree; technical degree preferred.
  • Knowledge of advanced problem-solving methods like Six Sigma; Green or Black Belt preferred.
  • Strong communication skills, with an emphasis on written and presentation abilities.
  • Experience in Project Management and planning equipment shutdowns required.
  • Track record of managing capital projects, specifically facility remodels for GMP space.

Responsibilities

  • Oversee site activities to ensure successful project completion.
  • Adhere to and enforce company Engineering policies and procedures.
  • Ensure safety, compliance, and effectiveness of all work and installations.
  • Maintain accurate Engineering, project, and Maintenance documentation.
  • Provide project status updates to VP Engineering and project teams.
  • Act as liaison among project stakeholders, including external firms and internal teams.
  • Address technical issues throughout the project lifecycle to meet scope, cost, and schedule goals.
  • Facilitate effective handover of facilities and utilities to end users.

Benefits

  • 100% employer paid medical plan.
  • Dental and Vision insurance with FSA & HSA options.
  • Employer-paid Life Insurance and Employee Assistance Program.
  • Short-term and long-term Disability Insurance.
  • Up to 4% 401K matching, fully vested from day one.
  • Generous Paid Time Off including vacation, sick leave, and holidays.
  • Tuition Reimbursement of up to $5,250 after 6 months of employment.
  • No limit on a $1,000 Referral Bonus Program.
  • Eligibility for an annual bonus program.
Full Job Description
The Construction & Facility Project Engineer reports directly to the VP, Engineering and is directly responsible for the management and execution of Engineering related activities carried out within their assigned area(s) of responsibility (capital projects, utilities, equipment, etc.). This includes the management of internal company resources, (assets, financial and personnel), external professional engineering and other firms as part of the execution of equipment, facility or utility modification / upgrade, or expansion projects. This direct management responsibility includes all support activities and functions necessary to ensure successful completion of project and / or Engineering objectives, including capital and expense projects.

Essential Functions:
  • Manage site activities necessary for successful execution of projects and ensure these are completed as necessary to tie in with the overall project execution.
  • Ensure all company and site Engineering policies and procedures are adhered to.
  • Ensure all work carried out and equipment installed is safe, effective, and compliant with industry standards.
  • Ensure all work undertaken is reflected accurately in up-to-date Engineering, project, and Maintenance files.
  • Report project status to the VP of Engineering, project team members and project management personnel.
  • Serve as liaison between professional Engineering firm(s), construction firms, service firms, and site project team members involved in the project(s) at hand.
  • Manage and resolve technical issues or changes arising throughout the project life cycle while also ensuring the overall project objectives of scope, cost and schedule are adhered to.
  • Ensure all facilities, utilities and / or equipment are handed over effectively to end users.
  • Apply engineering expertise toward the development and continuous improvement of departmental toolsets, such as operational procedures, design specifications, and whitepapers.
  • Perform any other activities as directed by the VP Engineering. Leads consistently in productivity, quality and teamwork metrics.
  • Adheres to all applicable procedures, cGMPs, company policies and any other quality or regulatory requirements.
    1. (For example: OSHA, DEA, FDA, EMEA, ANVISA, HS&E, etc.)

Supervisory Responsibilities:

  • Supervision of employees and vendors may be required.


Experience and Necessary Skills:
  • 5 years minimum experience in managing facilities for a cGMP FDA regulated pharmaceutical manufacturing environment; 2 or more years aseptic processing facility preferred.
  • Knowledge of cGMP guidelines/standards.
  • Bachelor's degree; technical degree preferred.
  • Advanced problem solving such as Six Sigma and Lean training, Green Belt or Black Belt preferred.
  • Demonstrated written and oral communications skills including strong presentation skills.
  • Project Management and annual equipment shutdown planning experience required.
  • Experience in managing capital projects including facility remodels for GMP space.
  • Strong results orientation.
  • Excellent matrix management skills and organizational skills.
  • Proficient in Microsoft Office products including Project, Outlook, Excel, and Word.

Benefits:
  • Smart healthcare coverage options that rewards wellness (and puts money back in your pocket!)
  • Flexible Spending & Health Savings Accounts (FSA & HSA) available
  • Dental & Vision insurance
  • Employer Paid Life Insurance & Employee Assistance Program
  • Short Term & Long-Term Disability Insurance
  • Up to 4% 401K Matching (100% vested on day one!)
  • Generous Paid Time Off Options - vacation, sick, paid leave and holidays!
  • $5,250 Annual Tuition Reimbursement after 6 months
  • $1,000 Referral Bonus Program with no limit
  • Eligible for annual bonus program


Timeline: We will be accepting applications on an ongoing basis until position is filled.

*Please note that we do not work with third-party recruiters or agencies for this position. If you are a qualified candidate and wish to apply for this job, please do so directly through our official application process. We appreciate your understanding and cooperation in this matter.

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About Leiters

Leiters is a pharmaceutical company that specializes in developing and manufacturing sterile injectable products. The company was founded in 1926 and is headquartered in McKinney, Texas. Leiters has a state-of-the-art manufacturing facility that is FDA-approved and operates under current Good Manufacturing Practices (cGMP). The company's products are used in hospitals, surgery centers, and clinics across the United States. Leiters is committed to providing high-quality products and exceptional customer service to its clients.
Learn more about Leiters
Size
400 employees
Industry
Net Income
$10 million
5 Year Trend
+10%
Revenue
$100 million

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