Manager, Mechanical Process Engineering 5486

Title: Manager, Mechanical Process Engineering (Life Sciences)

Location: Greater Baltimore, MD

Schedule: Hybrid with 2 days onsite each week

Qualifications, skills, and all relevant experience needed for this role can be found in the full description below.

About the Opportunity:

Our client is seeking a Manager, Mechanical Process Engineering to lead a growing Life Sciences engineering practice focused on pharmaceutical, biotechnology, and advanced manufacturing projects. This leadership role combines technical expertise, operational management, team development, and client engagement.

In this role, you will oversee a multidisciplinary engineering team, support complex project execution, contribute to strategic business growth, and serve as a technical resource for process engineering initiatives. You'll have the opportunity to influence project outcomes, mentor engineering professionals, and support clients operating in highly regulated environments.

About the Organization:

Our client is a well-established engineering and technical services firm that supports clients throughout the project lifecycle, from planning and design through implementation and operational support. The organization serves highly regulated industries and is recognized for delivering practical engineering solutions, technical expertise, and strong client partnerships.

Key Responsibilities:

• Lead day-to-day operations of the Life Sciences Process Engineering group while ensuring alignment with company standards, quality expectations, and business objectives.
• Provide technical leadership and guidance related to pharmaceutical, biotechnology, and GMP-regulated process engineering projects.
• Drive project performance related to scope, budget, schedule, and quality.
• Mentor, develop, and support engineering staff through coaching, training, performance management, and career development initiatives.
• Manage project staffing and resource allocation to ensure appropriate technical expertise is assigned to project work.
• Maintain and enforce quality assurance and quality control procedures.
• Conduct employee performance reviews and support workforce planning activities.
• Assist with business development efforts, including client meetings, facility assessments, proposal development, scope creation, and engineering fee estimates.
• Build and maintain strong relationships with existing and prospective clients.
• Collaborate with engineering leadership and other business units to establish and improve engineering standards, best practices, and execution processes.
• Serve as a technical subject matter expert for life sciences process engineering projects.
• Research and interpret applicable regulatory requirements, industry standards, and engineering codes.
• Prepare engineering analyses, technical studies, design documentation, and project reports.

Qualifications:

• Bachelor's degree in Chemical Engineering, Mechanical Engineering, or a related engineering discipline.
• Advanced degree in Biotechnology or a related field is preferred.
• NCEES Model Law Engineer and/or NCEES Record preferred.
• Minimum 13 years of process engineering experience supporting pharmaceutical, biotechnology, or life sciences manufacturing environments.
• Minimum 5 years of consulting engineering experience supporting facility, utility, and process system design projects.
• Experience preparing construction documents and technical specifications for regulated manufacturing facilities.
• Minimum 5 years of experience developing:

o Process Flow Diagrams (PFDs)

o Piping and Instrumentation Diagrams (P&IDs)

o Equipment specifications

o Piping specifications

• Demonstrated ability to function as a technical leader for process and utility system design projects.

Preferred Experience:

• Pharmaceutical validation, commissioning, qualification, and quality systems.
• Understanding of regulatory compliance requirements, risk management practices, and GMP manufacturing operations.
• Experience designing or supporting:

o Purified Water and Water for Injection (WFI) systems

o Process waste systems

o Process gases and specialty utility systems

o Clean utility infrastructure

• Familiarity with manufacturing and laboratory equipment such as:

o Bioreactors

o Mixing systems

o Chromatography equipment

o Filtration systems

o Single-use technologies

o Sterilization systems

o Controlled-temperature storage systems

• Development of User Requirement Specifications (URS).
• GMP equipment planning and equipment lists.
• Process utility demand calculations and system sizing.
• Facility planning and process layout development for pharmaceutical, biotechnology, cell therapy, or related manufacturing environments.
• Commissioning, Qualification, and Validation support, including IQ/OQ/PQ activities.

Additional Requirements:

• Ability to perform site visits and field investigations as needed.
• Willingness to travel periodically to client locations.
• Ability to work in a hybrid environment with regular office presence.
• Strong organizational and documentation skills.
• Ability to manage multiple priorities simultaneously. xhyhwjd
• Excellent communication, leadership, and team-development capabilities.

Compensation & Benefits:

• Base Salary: $160,000 - $185,000, depending on experience
• Eligible for overtime compensation
• Annual performance and profit-sharing incentive opportunities
• Paid Time Off and company holidays
• Comprehensive medical, dental, and vision coverage
• Company-paid life insurance and long-term disability coverage
• 401(k) plan with employer match

Additional Benefits:

• Opportunity to lead impactful engineering initiatives within the life sciences sector
• Flexible work environment and scheduling options
• Collaborative, team-oriented culture
• Professional development and continuing education support
• Tuition assistance and industry association reimbursement programs
• Career advancement opportunities within a growing organization