Jr/Mid Validation Engineer
Company: Delta Project Management, Inc.
Posted on: February 25, 2021
Validation - Facility/Equipment/Utility Validation / Delta PM
was founded in 2006 with a mission to deliver successful outcomes
for its employees, our clients, and patients through exceptional
relationships, collaboration, and execution. As a company dedicated
to the Life Sciences, we have the ability to impact lives in a
positive and meaningful way. We provide Validation, Project
Management and Quality Assurance solutions that enable our clients
to develop and deliver drug products to their patients with quality
and speed. Delta PM has established itself as a top provider of
staff and expertise in the Life Sciences Industry, and we now count
8 of the top 10 largest biopharma companies in the San Francisco
Bay Area as our customers, and in total work with nearly 30 clients
from coast to coast. Our goal is to deliver the best technical
expertise with a focus on fostering long-term relationships based
on trust, and to always go above and beyond to reach project
milestones and objectives. Professional growth for our employees is
very important here at Delta PM, and this creates a lot of great
opportunities for our team members. We are looking for "Deltoids"
who embody our core values of being people-focused, and
demonstrating integrity and excellence in their work on a daily
basis. If you enjoy working in a collaborative, fast-paced, and
continuously growing environment, we welcome a conversation to let
you know what makes us different from the rest. Come join our team!
The Validation Engineer/Specialist I and II is an entry to mid
level position primarily responsible for execution of qualification
and validation activities to drive overall quality and compliance
at the assigned client's site. The Validation Engineer/Specialist I
and II may be part of a larger team executing a specific project
scope or may act in a staff augmentation role by executing a
variety of validation deliverables. Client site work includes
validation support for installations and modifications of
biomanufacturing equipment, utility systems, computerized systems,
laboratory instrumentation, and facilities. Client sites are
located in the greater Boston, MA area. Key skills include creating
commissioning and qualification documentation (commissioning and
I/OQ protocols), executing commissioning and qualification
activities, authoring summary reports, and supporting any other
validation needs related to the project. Essential Duties and
- Participate in project teams executing various validation
projects under the direction of a project manager or validation
- Generate/Revise Commissioning, Installation, Operational and
Performance Qualification (IQ/OQ/PQ) Protocols for various life
science lab, computer system, manufacturing and packaging equipment
- Execute Commissioning, Installation, Operation and Performance
Qualification Protocols for various life science lab, computer
system, manufacturing and packaging equipment and utilities.
- Participate in issue identification, investigation and
mitigation. Generate test problem reports.
- Generate associated validation summary reports.
- Provide routine progress and issue update to project team.
- Perform temperature mapping and other miscellaneous validation
- Participate in client Validation teams in executing routine
Validation deliverables in a staff augmentation role. Required
Education and Experience
- BS in chemical, biomedical or biochemical engineering,
biological sciences, or related field/experience.
- 0-5 years relevant industry experience for Validation
- 5-10 years relevant industry experience for Validation
- Working knowledge of cGMP manufacturing as well as regulatory
regulations and requirements for biotechnology, pharmaceuticals and
- Ability to think critically and demonstrate troubleshooting and
- Able to function efficiently and independently in a fast paced,
- Able to function and contribute as part of a team.
- Possess excellent interpersonal, verbal and written
communication skills. Preferred Education and Experience
- Previous experience working in a cGMP manufacturing
- Previous experience writing and executing GMP documentation,
preferably Validation protocols such as Installation, Operation and
Performance Qualification documents.
- Understanding of GMP production facility utilities and their
application, such as Water for Injection (WFI), Cleanroom
Environments (HVAC), Clean Steam and process gases
- Understanding of process fundamentals for at least one of the
- o Small molecule chemical synthesis
- o Monoclonal antibody or protein biomanufacturing
- o Cell therapy and regenerative medicine
- o Analytical QC laboratories
- o Computerized Systems
- o Packaging
- Understanding of quality systems such as change control and
Keywords: Delta Project Management, Inc., Boston , Jr/Mid Validation Engineer, Engineering , Boston, Massachusetts
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