OverviewSSOE is seeking an experienced Senior Mechanical Engineer to support the planning, design, and execution of complex pharmaceutical and life sciences capital projects. Our teams partner with leading pharmaceutical and biotechnology companies to deliver manufacturing expansions, laboratory facilities, cleanroom environments, process utility systems, and facility modernization projects. The successful candidate will serve as a technical leader, collaborating with multidisciplinary teams to improve production capacity, regulatory compliance, operational reliability, and speed-to-market.
Responsibilities
A Typical Day Might Include:
- Lead mechanical engineering efforts for complex pharmaceutical, biotechnology, and advanced manufacturing facilities, supporting strategic capital investments.
- Serve as Mechanical Engineering Lead on pharmaceutical and life sciences capital projects ranging from facility modifications and equipment installations to major manufacturing expansions and greenfield developments.
- Drive successful project execution through planning, conceptual design, detailed engineering, procurement support, construction, commissioning, qualification, startup, and operational readiness.
- Develop engineering solutions for process utilities, manufacturing support infrastructure, facility systems, and equipment integration within GMP-regulated environments.
- Support facilities involved in sterile manufacturing, biologics, fill-finish operations, oral solid dose production, laboratory environments, and other regulated pharmaceutical operations.
- Perform engineering assessments and feasibility studies for facility expansions, modernization initiatives, technology transfer projects, and manufacturing capacity improvements.
- Develop project scopes, schedules, budgets, engineering concepts, technical documentation, and capital cost estimates.
- Collaborate closely with process, validation, quality, automation, architecture, structural, electrical, and construction teams to deliver integrated project solutions.
- Interface directly with client engineering, operations, maintenance, quality, validation, and leadership teams.
- Provide technical leadership for clean utility systems, process support systems, sanitary design applications, and facility infrastructure improvements.
- Ensure designs comply with FDA, cGMP, corporate, and industry standards.
- Leverage SSOE’s integrated architecture, engineering, process, automation, and project delivery capabilities to develop solutions that are practical to construct, qualify, maintain, and operate.
- Support proposal development, client presentations, project pursuits, and long-term client relationship growth within the pharmaceutical and life sciences sector.
- Coach, mentor and develop less experienced engineers and designers and provide technical guidance across project teams.
- Travel required approximately 25%.
Typical Project Types:
- Pharmaceutical manufacturing facility expansions and renovations
- Sterile manufacturing and fill-finish production facilities
- Biotechnology and advanced therapeutics facilities
- GMP laboratories and research environments
- Cleanroom and controlled manufacturing environments
- Facility utility modernization and infrastructure improvement projects
- Manufacturing capacity expansion and technology transfer initiatives
Qualifications
Qualifications You’ll Need on Day One:
- Bachelor’s Degree in Mechanical Engineering required.
- PE license or progress toward licensure strongly preferred.
- 10+ years of engineering experience, including pharmaceutical, biotechnology, or life sciences facility projects.
- Significant experience supporting FDA-regulated and cGMP manufacturing environments.
- Demonstrated leadership skills + experience leading multidisciplinary capital projects with responsibility for scope, schedule, budget, and client communication.
- Demonstrated experience leading projects from conceptual design through construction, commissioning, qualification, and startup.
- Knowledge of pharmaceutical facility design, manufacturing operations, process support systems, and clean utility infrastructure.
- Consulting engineering experience supporting pharmaceutical or biotechnology clients strongly preferred.
- Strong communication, facilitation, project management, and team leadership skills.
- Proficiency with Microsoft Office and familiarity with AutoCAD or similar CAD platforms.
- Salary Range: $150,000 to $160,000 a year depending on location, education, experience, and any certifications that are directly related to the position.
- Benefits include health, dental and vision insurance, life insurance, 401K, PTO & paid holidays.
Preferred Experience:
- Fill-finish manufacturing operations
- Sterile production environments
- Biotechnology manufacturing facilities
- Pharmaceutical laboratories and pilot plants
- Brownfield facility renovations and expansions
- Clean utility and process support systems
- Commissioning, qualification, and validation activities
