Job Title: Commissioning & Qualification Lead Consultant
Brooksource
Location: Site-Based (with potential travel to multiple sites)
Job Type: Long-Term Contract with Opportunity for Full-Time Employment Conversion
Role Overview:
Brooksource is seeking a highly skilled and experienced C&Q (Commissioning and Qualification) Lead Consultant to join our team, partnering with a leading pharmaceutical manufacturing organization. The ideal candidate will possess a robust technical background, proven leadership abilities, and extensive experience in the Life Sciences industry. This role requires a site-based presence with frequent travel to various locations. The focus will be on parenteral or API workstreams for new site startups.
Role Responsibilities:
- Oversee and manage the C&Q schedule to ensure timely completion of all activities.
- Oversee and implement the defined C&Q Program, ensuring consistency with other C&Q leads.
- Provide technical oversight and guidance to various C&Q teams executing the work.
- Ensure tracking and reporting tools are properly set up and communicated to relevant stakeholders.
- Demonstrate technical knowledge and experience in one or more workstreams to ensure effective oversight during C&Q delivery.
- Review, understand, and implement the existing CQ program, providing adequate training and management for the C&Q team across multiple workstreams.
- Oversee daily activities of the C&Q team, including conducting daily meetings, assigning tasks, and delegating responsibilities.
- Promptly escalate unresolved issues such as delayed approval of deliverables, field execution problems, or alignment issues with other disciplines.
- Onboard new staff and provide orientation and training necessary to support C&Q activities.
- Work collaboratively with project support groups (automation, construction, engineering, end users) and their management to influence decisions and facilitate C&Q work completion.
- Scope and manage the sourcing of test equipment and craft support needed for field testing.
- Manage and report on workload and progress weekly to the C&Q Lead and provide monthly progress metrics to the project leadership team.
- Ensure that the C&Q team adheres to all project safety requirements and procedures, supplementing the safety program for C&Q-specific activities as necessary and serving as a positive safety model.
Role Requirements:
- BS in Engineering or equivalent experience.
- Minimum of 5+ years in the Life Sciences industry, including operations or manufacturing with technical experience in finished product storage and operations.
- At least 5+ years of C&Q experience.
- Demonstrated leadership and people management skills.
- Proficiency in GMPs, regulatory requirements, equipment commissioning, and qualifications.
- Excellent written and verbal communication skills, able to interact effectively with both technical and non-technical staff.
- Ability to be site-based full-time with frequent travel to multiple sites.
