Upstream Associate – Shift

The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

Role Functions (Functions include, but are not limited to, the following)

* Work with the manufacturing operations group, project design team, the CQV team, the Automation/CSV reps to facilitate the development and validation of the Biotech facility manufacturing facility.

* Support Equipment Design/ HAZOP and Room programming reviews as per requirements.

* Support Operations team to consistently deliver on specific area Key Performance Indicators (KPIs),

e.g. EHS metrics, Production Plan, OEE, compliance and team training.

* Execute commercial manufacturing processes according to established work instructions and

Standard Operating Procedures.

* Work as part of a dedicated process team where flexibility and teamwork are a key requirement

* Generate SOPS/Electronic Batch Records for start-up. * Adhere to Right First-Time principals

* Provide assistance and/or support maintenance, engineering, quality or other colleagues as requested.

* Escalate issues as appropriate to Process Lead

* Maintain a high level of personal expertise and working knowledge of all aspects of the manufacturing process and process equipment through continuous training and development. * Liaise with other groups and individuals to ensure planning of tasks is effective and linked into * the manufacturing process plan.

Experience, Knowledge & Skills General

* Demonstrated successes in a team environment, such as project teams, Lean Six Sigma team, etc.

* Demonstrated problem solving capabilities.

* Knowledge of applying Lean Six Sigma and Lean methodologies in a workplace environment

Technical

* Experience in a highly regulated pharmaceutical manufacturing environment is desirable.

* Start-up experience in a large-scale commercial drug substance facility desirable but not essential.

* Good understanding of Upstream/Downstream Processing and experience an advantage.

People

* Ability to interact with multiple stakeholders across numerous departments * Excellent communication skills and the ability to work in a cross functional collaborative environment. * Good interpersonal skills, attentiveness, and an approachable manner for interactions with inter departmental colleagues. * High degree of problem-solving ability and adherence to scheduled timelines

Qualifications & Education

* Minimum of a Level 7 qualification in a science or engineering discipline. * A level 6 with a minimum of 3 years’ experience in a GMP Manufacturing requirement shall be deemed equivalent.