Deviation Engineer (Pharma/Biotech)

Responsible for the initiation, investigation and completion of process deviations aimed at identification of root cause, and implementation of correct actions to prevent recurrence. The position is expected to work in a cGMP environment, have working knowledge of Biopharmaceutical manufacturing processes, the ability to manage multiple ongoing projects concurrently, have strong meeting facilitation and conflict resolution skills, a strong technical writing capability, be action oriented, and be compliant minded while performing investigations.

Main Responsibilities:

Technical writing for the educated but uninformed reader, translate moderate to complex scientific events into a brief and cohesive report as a finished product.

Accurately capture immediate actions and containment of the event

Address comments from both internal and external clients on the compiled final report.

Gather Data from various sources across the client site, perform of Root Cause

Analysis to determine the most likely cause of the deviation investigation,

Assessment of event for impact to SISQP, Perform Trending Analysis,

Identification of Corrective and Preventative Actions to reduce deviation recurrence, performance of Risk Assessments, Causing Mapping

Meeting Facilitation and participation, aligning internal review team and area subject matter experts on an agreed to investigational path forward.

Conflict resolution, problem solving in a cross functional setting, and ability to keep the meeting on track to achieve objective.

Management of multiple projects and timelines concurrently.

Ability to adhere to standard timeline, and escalate actions appropriately for resolution in a timely manner.

Routine interaction with the customer, including compilation of Power Points to communicate investigational current status, Alignment meetings, facilitated reviews, CAPA discussions, Comments resolution

When required, Work on the manufacturing floor for data gathering, observing of processes for investigations, and performance of associate interviews

About You:

Bachelor of Arts/Science or equivalent combination of education minimum.

Preferred area of study: Biochemistry, Chemical Engineering, Biology or other relevant science discipline

1-3 years’ experience; Prior experience technical writing and in a manufacturing, environment preferred

Must have the ability to work in a fast paced, high workload environment, and be able to manage multiple projects and objectives for on-time event closure.

Must work well on a team, and be able to trouble shoot and problem solve in a cross functional team setting.

Must be proactive, action oriented, and have the ability to adapt to a change.

Must be able to identify and flag risks in a timely manner to keep deliverables on track.

Must have strong communication skills both verbally and written.

Proven logic and decision-making abilities, critical thinking skills Strong written and verbal communication skills are required.

Ability to read and comprehend complex subjects.

Strong typing and computer skills, including efficiency using Microsoft

Office Suite (Word, Excel, PowerPoint), and familiarity with cGMP quality systems

Duration: 12 months. Option to extend/convert subject to performance review.