Pharmaceutical Plant Project Engineer - III

The International Society for Pharmaceutical Engineering, Inc.; Spokane (WA); Hybrid; USD 115,000 - 130,000; Full time

Benefits offered by this job

Relocation package

Medical insurance

Vision insurance

Dental insurance

Job summary

The International Society for Pharmaceutical Engineering, Inc. is seeking a Plant Project Engineer – III for our Spokane, WA site to lead large-scale facility projects in a growing Biopharma CDMO.

The role expects 7+ years of project management and 3+ years in Biopharma, with experience in utility systems and regulatory compliance. Reporting to the Engineering Supervisor, you will drive multi-disciplinary teams, develop detailed specs, and oversee RFQs for external partners while ensuring strict

Qualifications

• Bachelor's of Science in Engineering or related technical degree.
• 7+ years of Engineering Project Management / Project Engineering Experience.
• 3+ years of Engineering experience in the BioPharma industry.
• Facility or Manufacturing Engineering Experience.
• MS Office suite (Word, PowerPoint, Excel) experience.
• Ability to work through ambiguous and complex situations, influencing outcomes.

Responsibilities

• Provides technical support of engineering facility projects including facility and utility expansion, compliance upgrades, cost reduction, contract manufacturing, process improvements, construction projects.
• Develops expertise in facility engineering, including design, modification, and troubleshooting pharmaceutical systems such as HVAC, Clean Steam, WFI, electrical.
• Ensures regulatory compliance for facility and processes with local, state, federal, and international agencies.
• Manages major capital and expense facility projects per PM guidelines with scheduling, budgeting, and documentation.

Skills

Project management

Engineering

BioPharma

Education

Bachelors in Engineering

Tools

MS Office

AutoCAD

ERP SAP

Job description

Our client – a global and growing BioPharma CDMO company needs a Plant Project Engineer – III with Pharmaceutical Industry experience at their expanding plant in WA state, Excellent total comp. up to $143K+ with excellent Benefits (starts Day 1) + Generous Relocation Package. Client will support H1B visa transfer if needed.

Job Posting # 2726

Job Title: Pharmaceutical Plant Project Engineer - III Overnight Travel: 10%

Location: Spokane, WA

Relocation: YES - Theclient offers a generous package for relo assistance.

Compensation: Salary range up to $130K + Annual Bonus (10 %)

Full Benefits: Medical, Vision, Dental, 15 days' vacation/Sick time, 10 - Holidays, 401k (match up to 4%)

Our client is a growing CDMO company in the Pharmaceutical Industry. They are a part of a global parent company with sites in many countries with around 1,300 people at this site in Spokane, WA.

This is an integrated contract development and manufacturing organization (CDMO) offering specialized Aseptic Sterile manufacturing, filling and lyophilization of drug products in Vials.

Group Info: Be part of the Plant Engineering group of around 60 technical people. This role will be responsible for the technical aspects of 1 of the 4 lines

This role will report to the Engineering Supervisor

Note 1: The company recently completed their 3rd state-of-the-art Sterile Liquid compounding & Vial Filling line and are currently expanding again with a 4th line at this growing plant site.

Note 2: Client will support transfer of existing H1B Visa for this permanent direct hire role, but will not sponsor for a new H1B visa.

Job Summary

• The Project Engineer III provides pharmaceutical engineering expertise primarily in the area of facility engineering.
• This position will manage large-scale projects and multi-disciplinary project teams, and will provide technical direction for complex projects and exhibit superior communication skills with all levels of employees.
• This individual will be recognized as an authority in multiple areas of facility pharmaceutical engineering and provide leadership and guidance to others.

Job Functions and Responsibilities in cGMP settings.

• Provides technical support of engineering facility projects including facility and utility expansion, compliance upgrades, cost reduction, contract manufacturing, process improvements, construction projects, etc.
• Through education and experience provides expertise in the area of facility engineering. This includes design, modification and troubleshooting pharmaceutical systems such as HVAC, Clean Steam, WFI, electrical and knowledge of pharmaceutical construction methods.
• Responsible for contributing knowledge of regulatory requirements for the facility and processes to ensure compliance to local, state, federal and international regulatory agencies.
• Autonomously manages major capital and expense facility projects in a manner that is compliant with the "Project Management Guidelines" system. This system includes methods for scheduling, budgeting, meeting management, teamwork, communication, and documentation of a multi-departmental project team.
• Participates in the compliance to both short-term and long-term company objectives as defined by upper management.
• Development of detailed specifications and RFQs to be used by A&E firms, contractors or equipment manufactures to accurately quote on projects being pursued by the company.
• Responsible for developing and using systems of engineering documentation required by regulatory agencies and in compliance with generally accepted engineering guidelines, SOPs, or quality standards.

Candidate Must Have

• Bachelors of Science in Engineering or related technical degree.
• 7+ years of Engineering Project Management / Project Engineering Experience
• 3+ years of Engineering experience in the BioPharma industry
• Facility or Manufacturing Engineering Experience
• MS Office suite (Word, PowerPoint, Excel) experience
• Demonstrated ability to work through ambiguous and complex situations, influencing outcomes, and driving a multi-disciplinary team without direct authority.

Candidate Nice to Have

• BS in Mechanical, Chemical, Electrical, Manufacturing engineering
• Advanced degree or PE or PMP certification
• Experience with PM Software - MS Project, Design software - AutoCAD & ERP - SAP
• Experience with Pharma sterile aseptic manufacturing, filling, Lyophilization
• Interfacing with OEM equipment vendors, Construction/consulting partners

Keywords: Projects, Plant Project, engineering, Pharma, CDMO, manufacturing, plant, FDA, GMP, Sterile Aseptic liquid filling, Isolators, Clean rooms, Lyophilization, contract Manufacturing.