Project Engineer II to III

Concuir, Inc

$90K — $135K *
Pharmaceuticals & Biotech
Less than 5 years of experience
Job Overview by Ladders

Qualifications

  • 2-10+ years' experience in Pharmaceutical, Biotech, or Medical Device industries
  • BS in Engineering (Chemical, Mechanical, Biomedical, or related)
  • 2+ years in a cGMP environment
  • Experience with equipment installation and commissioning, FAT/SAT, or C&Q
  • Strong communication skills, both verbal and written
  • Ability to build relationships with stakeholders and site teams
  • Willingness to work up to 100% on-site and travel up to 25%.

Responsibilities

  • Deliver on client expectations and maintain strong communication
  • Perform project deliverables aligned with timelines and budgets
  • Facilitate team accountability by escalating issues
  • Participate in cross-functional teams for process improvement
  • Support technology transfer and scale-up efforts with documentation
  • Provide technical assessments for validation and change control
  • Review vendor submittals for project alignment
  • Coordinate with partners during equipment installation to ensure readiness
  • Participate in troubleshooting and start-up of Process Equipment
  • Support Factory Acceptance Testing (FAT) activities
  • Generate and revise engineering specifications for manufacturing operations
  • Contribute to turnover package documentation for project close-out
  • Assist with deviation management during project execution
  • Cultivate client relationships for long-term partnerships
  • Represent Concuir at industry events to enhance visibility
  • Identify partnership opportunities within existing and prospective accounts
  • Foster a collaborative, inclusive team culture
  • Provide insights on regulatory trends and delivery models
  • Stay updated on life science industry developments.

Benefits

  • Support and guidance from Concuir's leadership team
  • Comprehensive benefits package including 100% covered medical, dental, vision
  • Life insurance and short- and long-term disability coverage
  • Generous maternity/paternity leave
  • 401K matching
  • Bonus compensation
  • Commuter and home office benefits
  • Uncapped paid time off (PTO)
Full Job Description
Consultant - Project Engineer II through III

Compensation package annual salary is ($90,000 - $110,000 DOE) and ($100,000 - $135,000 DOE), respectively, plus quarterly bonuses (3-10% of salary target, depending on performance)

JOB DESCRIPTION:

As a full-time employee of Concuir, Inc, you will provide consulting services to pharmaceutical and/or biotech manufacturing clients. In this role, you will quickly learn common client practices, recommend, and implement improvements to reach project goals and have the opportunity to scale-up and bring new products into manufacturing. You will be able to utilize your experience as well as benefit from Concuir's portfolio of project management and cGxP best practices to drive your overall success. Projects range from design through qualification of production equipment, utilities modification, implementation of new facilities, and process scale-ups. You will drive to understand our unique client needs to deliver successful results. Providing excellent customer service to our clients and ultimately the patients they serve is critical. Your Concuir leadership will work with you to guarantee internal processes and support are in place to ensure your positive results.
  • You will execute projects day-to-day for your clients with mentorship and technical problem-solving collaboration from your manager and team.
  • You will interface with process owners and project stakeholders to reach our clients' objectives. This includes resolving critical issues and gathering appropriate feedback from the team.
  • Depending on scope and project complexity, you may be responsible for delivering between 1 and 3 projects concurrently.


RESPONSIBILITIES:

  • Deliver on client expectations and maintain strong stakeholder communication throughout the project life cycle.
  • Perform Capital and/or Expense project deliverables in alignment with project timelines, budgets, and objectives.
  • Facilitate team communication and accountability by escalating issues appropriately.
  • Participate in cross-functional teams dedicated to process improvement, efficiency, and optimization.
  • Support technology transfer, construction activities, and scale-up efforts with strong technical documentation and writing.
  • Provide technical assessments for investigations, validation, and change control.
  • Review vendor submittals and technical documentation to ensure alignment with project design and user requirements.
  • Coordinate with project partners during equipment installation to ensure readiness and adherence to design intent.
  • Participate in troubleshooting and start-up of Process Equipment and Utilities.
  • Support Factory Acceptance Testing (FAT) activities, including participation, documentation review, and issue resolution.
  • Generate and revise engineering specifications to support process equipment and manufacturing operations.
  • Execute studies and comparability protocols for manufacturing operations.
  • Contribute to turnover package (TOP) documentation to support project close-out requirements.
  • Assist with deviation management and change request documentation as part of project execution.
  • Cultivate and expand strategic client relationships to ensure satisfaction and long-term partnerships
  • Represent Concuir at industry events, conferences, and networking forums to enhance brand visibility
  • Identify partnership opportunities and develop new revenue streams within existing and prospective client accounts
  • Foster a collaborative, inclusive team culture consistent with company values
  • Provide strategic insights on regulatory trends, delivery models, and execution strategies across engagements
  • Consistently model Concuir's core values in client delivery and internal leadership
  • Stay updated with the latest developments in the life science industry, including regulatory changes, market trends, and emerging technologies


QUALIFICATIONS:

  • 2-10+ years' experience working on capital or expense projects in Pharmaceutical, Biotech or Medical Device industries.
  • BS in Engineering degree required (Chemical, Mechanical, Biomedical, or related).
  • 2+ years of experience in a cGMP environment required.
  • Experience with equipment installation, commissioning, FAT/SAT, or C&Q.
  • Self-starter with strong communication skills, both verbally and in writing.
  • Ability to work with and build good relationships with stakeholders and the wider site teams.
  • Ability and desire to work within a high-performing team and collaborate effectively and respectfully with internal and external staff at all levels and of diverse backgrounds.
  • Previous consulting or owner-side project experience preferred.
  • Ability to work up to 100% on-site at client facilities.
  • Willingness and ability for up to 25% travel.


What We Are Offering

  • Full support and guidance of Concuir's leadership team and business practices (Recruiting, HR, Operations, Client Relationships, and Service Execution) to grow your team.
  • Comprehensive compensation and benefits as a full-time Concuir employee: 100% employee-covered medical, dental, and vision. Life insurance, short- and long-term disability, maternity/paternity leave, 401K matching, bonus compensation, commuter benefits, home office benefits, uncapped PTO, and more.

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