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Manufacturing Deviations Specialist
Dps Group Global
Global consultancy delivering engineering, construction management & advisory for high‑tech manufacturing facilities.
Monitor process operations to ensure compliance with specifications.
Develop batch records, SOPs and training materials as needed.
Closely partner with peers for rapid review of batch-related documentation.
Participates in determining objectives of assignment and plans, schedules and arranges own activities in accomplishing milestone achievements.
Enforce adherence to current good manufacturing practices, standard operating procedures, and manufacturing documentation. Establish and follow written procedures for the clear and accurate documentation of equipment operation and process instructions, and of process data.
Author and review SOPs, policies and batch production/testing records to ensure compliance and adherence to regulations/cGMP operations.
Identify and assemble proper SMEs for triage, determine immediate actions taken, document impact assessments, lead RCA, develop appropriate CAPAs
Utilize knowledge to improve operational efficiency.
Must be able to work under general direction to plan, coordinate, and ensure completion of engineering team deliverables.
Assist in the investigation of procedural deviations.
Participate in quality oversight of manufacturing through real-time observations of activities.
Lead, write and review deviations and investigations for VCGT, including the manufacturing, facilities, supply chain/materials management and support QC deviations as necessary.
Reviews minor manufacturing deviations.
Oversees execution of CAPAs, deviations and change controls in support of PCV manufacturing.
What you bring
gmp
bachelor’s
qms
cell manufacturing
deviations
leadership
Deviations Specialist (Pharmaceutical)
At least 3-4 years of QA or Manufacturing experience in a GMP manufacturing environment with a Bachelor’s Degree in Biology, Chemistry, Chemical engineering, Biomechanical engineering, Bioengineering, Biomedical Engineering, Biochemistry or related field.
Demonstrate a general knowledge of standard manufacturing compliance, quality disposition, and quality system review.
Excellent interpersonal, teamwork, and leadership skills required.
Ability to collaborate fluidly with peers, supervisors and cross-functional support groups required
Demonstrated understanding of the principles and applications associated with cell and gene manufacturing operations, maintenance/calibration, engineering, and validation
Proficiency in writing deviations
Exceptional written, oral communication, and organizational skills required
Proven track record of success in a fast-paced production environment at a biotech/pharmaceutical company preferably in GMP or GLP
Experience working in an electronic Quality Management System
Effective verbal and written communication skills.
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