Senior GMP Engineering Project Lead

Bachem; Vista (CA); On-site; USD 126,000 - 174,000; Full time

Benefits offered by this job

Annual performance bonus

Medical/Dental/Vision coverage

401(k) plan with employer contribution

Paid vacation, personal and sick days

Job summary

Bachem America seeks a Sr. Engineering Project Manager to lead the implementation of large-scale production processes and equipment, applying best-practice project management to capital projects.

This role oversees system start-up activities and ensures that engineers and operations staff are trained to operate and troubleshoot new equipment effectively. You will transfer proprietary manufacturing technology from Switzerland to America, guide equipment implementation to align with global

Qualifications

• Minimum of 5+ years of relevant work experience with a Master’s degree.
• Bachelor’s degree holders require 10+ years of relevant work experience.
• Associate’s degree holders require 15+ years of relevant work experience.
• Minimum of 8 years pharm/biotech experience in GMP-related capital projects.
• Knowledge of cGMP, pharmaceutical manufacturing methods and engineering principles.
• Technical knowledge of processes, equipment, and utilities (batch processing, tank, filtration, lyophilization, purified water systems).
• PMP certification (preferred).
• Strong MS Suite skills, particularly MS Project, SharePoint, etc.
• Excellent written and oral communication skills.
• Ability to lead engineering teams and manage capital projects.

Responsibilities

• Transfer Bachem proprietary manufacturing technology from Bachem Switzerland to Bachem America.
• Guide equipment implementation and align with global standards.
• Build manufacturing infrastructure mirroring Bachem Switzerland.
• Lead cross-functional teams (Quality, Production, Facilities, Engineering).
• Oversee CapEx projects for GMP laboratories and equipment including AHU, dehumidifiers, chillers, cleanrooms, lyophilizers, and controls.
• Develop and train staff on maintenance schedules for new equipment.
• Support Engineering Director on facility remodeling and expansion projects.
• Design and qualification activities for new and existing equipment.
• Create process and equipment drawings based on specs and standards.
• Lead design and construction of plant expansions and related capital projects.
• Coordinate with departments, contractors, and vendors.
• Perform process development studies and write GMP documents (SOPs, STPs, MBRs).

Skills

Project leadership

Cross-functional leadership

Communication

Problem solving

Education

Master’s degree in engineering/science/business

Bachelor’s degree in engineering/science/business

Associate’s degree in engineering/science/business

Tools

MS Project

SharePoint

Job description

Bachem America seeks a Sr. Engineering Project Manager to lead the implementation of large-scale production processes and equipment, applying best-practice project management to capital projects.

This role oversees system start-up activities and ensures that engineers and operations staff are trained to operate and troubleshoot new equipment effectively. You will transfer proprietary manufacturing technology from Switzerland to America, guide equipment implementation to align with global