Senior GMP Engineering Project Manager - Capital Projects

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

Benefits offered by this job

Annual performance bonus

401(k) plan with employer contribution

Comprehensive Medical/Dental/Vision

Paid vacation, personal and sick days

Competitive pay

Job summary

Bachem Americas is seeking a Sr. Engineering Project Manager to lead the implementation of large-scale production processes and equipment.

You will ensure engineers and operations staff are trained to operate and troubleshoot new equipment effectively. Responsibilities include transferring proprietary technology from Switzerland to the US, guiding equipment implementation, and overseeing GMP laboratories, AHU systems, lyophilizers, and related automation.

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).
• 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.
• 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.

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 plat‑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

Skills

Project management

Leadership

Communication

Cross-functional collaboration

Problem solving

Team leadership

Budgeting

Risk management

Process engineering

Regulatory knowledge

Education

Master’s degree in engineering, science, business or related field

Bachelor’s degree in engineering, science, business or related field

Associate’s degree in engineering, science, business or related field

PMP certification

Tools

GC

FTIR

NMR

KF

Job description

Bachem Americas is seeking a Sr. Engineering Project Manager to lead the implementation of large-scale production processes and equipment.

You will ensure engineers and operations staff are trained to operate and troubleshoot new equipment effectively. Responsibilities include transferring proprietary technology from Switzerland to the US, guiding equipment implementation, and overseeing GMP laboratories, AHU systems, lyophilizers, and related automation.