Sr. Engineering Project Manager

About the role

The Sr. Engineering Project Manager leads the implementation of large-scale production processes and equipment at Bachem, applying best-practice project management methodologies to capital projects. This role oversees system start-up activities and ensures that engineers and operations staff are fully trained to operate and troubleshoot new equipment effectively.

Responsibilities

• Transfer Bachem proprietary manufacturing technology from Bachem Switzerland to Bachem America.
• Leverage engineering design principles and large-scale production technologies used in Bachem Switzerland to guide equipment implementation and ensure alignment with global standards.
• Implement and build manufacturing infrastructure to mirror Bachem Switzerland utilizing experience gained in Bachem to maximize capabilities.
• Lead cross-functional teams (Quality, Production, Facilities, Engineering) within a matrix environment.
• Oversee CapEx projects for new GMP laboratories and equipment (AHU, dehumidifiers, chillers, etc.), cleanrooms and lyophilizers, as well as controls and automation associated with these activities.
• Develop and train employees on the utilization of maintenance schedules for new equipment.
• Support the Engineering Director on capital projects for facility remodeling and expansion.
• Perform activities associated with the design and qualifications of the new and existing equipment used in a manufacturing plant.
• Create new process and equipment drawings based on specifications and standards.
• Act as the lead project manager for the design and construction of new plant expansions and plant-related capital projects.
• Work with other departments, contractors, and vendors.
• Perform process development studies for new and existing projects. Write summary reports to support the process development data.
• Write standard operation procedures, standard test procedures, master batch records and other related GMP documents.
• Plan projects from inception to completion.
• Ability to maintain a live-up-to-date risk register, schedule, budget and issues log related to program/project activity.

Qualifications

• Master’s degree in engineering, science, business or related field with 5+ years of relevant work experience.
• Bachelor’s degree in engineering, science, business or related field with 10+ years of relevant work experience.
• Associate’s degree in engineering, science, business or related field with 15+ years of relevant work experience.
• Minimum of 8 years pharm/biotech experience.
• Work 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 etc.).
• Experience with peptides (preferred).
• General lab instrument (GC, FTIR, NMR and KF) knowledge and operation experience (preferred).
• PMP certification (preferred).
• Strong MS Suite skills, particularly MS Project, SharePoint, etc.
• Excellent written and oral communication skills.
• Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment.
• Ability to lead engineering teams in project management practices and assist engineering manager in developing site-wide procedures regarding managing capital projects.
• Ability to communicate in a proactive and solution-focused manner, including keeping management aware of potential issues.
• Strong interpersonal skills to influence and negotiate with Bachem functional managers.
• Communicate effectively and ability to function well in a team environment.

Pay

Base salary range: $126,317 - $173,686. Placement of new hires in this wage range is based on several factors including education, skill sets, experience, and training.

Benefits

• Competitive pay.
• Annual performance bonus.
• Comprehensive Medical/Dental/Vision coverage.
• 401(k) plan with employer contribution.
• Paid vacation, personal and sick days.