Commissioning and Qualification Lead
Apply NowCompany: Atika Technologies
Location: Walkersville, MD 21793
Description:
Role: Commissioning and Qualification Lead
Rate: $40/hr. C2C
Location: Walkersville, MD (onsite)
Visa: ny visa apart from H1
Duration: 12+ month
Commissioning and Qualification (C&Q) Lead at our Walkersville, Maryland site. This role will support the Endotoxin 2.0 project from March, 2025 Through December of 2026.
The candidate must have the following:
Strong understanding of validation processes and regulatory requirements specific to automated fill
lines, process equipment, and utilities, including GMP, FDA, EMA, and other applicable standards.
Demonstrated experience leading C&Q efforts on multiple large-scale projects, with references
provided to validate successful outcomes.
Proven track record of effectively leading and managing diverse teams, including direct reports and external resources.
Extensive knowledge of industry best practices for commissioning and qualification, with a focus on
regulatory compliance.
Commitment to being on-site for the duration of the project; local candidates are preferred to ensure
consistent presence and engagement.
Exceptional ability to communicate and collaborate with cross-functional teams, external C&Q firms,
and project stakeholders.
Strong skills in developing and managing C&Q documentation and delivering clear and concise
progress reports.
Ability to identify and mitigate risks, resolve issues, and ensure the successful execution of C&Q
activities within budget and schedule.
As a Lonza signatory in a critical project role, we will invest significant resources to train the candidate on Lonza policies and procedures. It is expected the candidate will remain on the project throughout the project duration.
Rate: $40/hr. C2C
Location: Walkersville, MD (onsite)
Visa: ny visa apart from H1
Duration: 12+ month
Commissioning and Qualification (C&Q) Lead at our Walkersville, Maryland site. This role will support the Endotoxin 2.0 project from March, 2025 Through December of 2026.
The candidate must have the following:
Strong understanding of validation processes and regulatory requirements specific to automated fill
lines, process equipment, and utilities, including GMP, FDA, EMA, and other applicable standards.
Demonstrated experience leading C&Q efforts on multiple large-scale projects, with references
provided to validate successful outcomes.
Proven track record of effectively leading and managing diverse teams, including direct reports and external resources.
Extensive knowledge of industry best practices for commissioning and qualification, with a focus on
regulatory compliance.
Commitment to being on-site for the duration of the project; local candidates are preferred to ensure
consistent presence and engagement.
Exceptional ability to communicate and collaborate with cross-functional teams, external C&Q firms,
and project stakeholders.
Strong skills in developing and managing C&Q documentation and delivering clear and concise
progress reports.
Ability to identify and mitigate risks, resolve issues, and ensure the successful execution of C&Q
activities within budget and schedule.
As a Lonza signatory in a critical project role, we will invest significant resources to train the candidate on Lonza policies and procedures. It is expected the candidate will remain on the project throughout the project duration.