Senior Engineer Manufacturing & Compliance
Key information
Job ad expired
Workload:
100%Contract type:
Permanent position-
Place of work:
Boudry
At Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science.In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.
The Senior Engineer, Manufacturing Compliance authors, owns and leads updates of GMP documents related to Bulk and/or Packaging Operations.
In this role, you will initiate and own deviations related to Bulk and/or Packaging Operations and leads investigation tasks as required. You will be supporting the Head of Bulk and/ or Packaging Operations in monitoring quality and performance metrics and acts as a referee for the operational team for GMP systems, documentation and training. Also, you will act as deputy to the Head of Bulk and/or Packaging.
Skills/Knowledge Required
- BS/MS in Engineering/Technical discipline or equivalent experience
- 8 years' experience in pharmaceutical validation, packaging or related field
- Sound knowledge of current international regulatory regulations, cGxP requirements and best practices, including 21 CFR part 11, 210 and 211, Annex 11, EU-GMP guidelines and GAMP Experienced in Health Authority inspections (preparation, process, presentations, responses drafting, etc).
- Knowledge of pharmaceutical facilities, manufacturing, and laboratory systems and processes.
- Well-developed ability to constructively work across functional areas and levels to achieve results,
- Strong verbal and written communication skills,
- Strong analytical, problem solving, influential and deductive skills,
- Capability to work with short deadlines and simultaneous activities,
- Excellent organizational and project management skills,
- Successful experience in direct people management,
- Fluent in English and in French.
Duties and Responsibilities
The Manufacturing Compliance Engineer's main activities are completed autonomously for the following tasks and responsibilities:
- Initiate deviations and participate to or lead on-the-floor investigations. Partner with QA and Boudry/Couvet Packaging or Bulk Operations to ensure assessments and investigations are exhaustive.
- Follow up and implement assigned CAPA's.
- Author and review manufacturing (bulk/packaging) documents, including specifications, working practices, Forms and logbooks. Follow up approval flow within electronic documentation system and facilitate all stakeholders' input to ensure documents are updated and approved in a timely manner.
- Lead risk assessments and risk management cross-functional teams (from draft to approval).
- Support Critical Quality Attributes and Critical Process Parameters definition and implementation.
- Perform complaint investigations linked to Manufacturing.
- Initiate, own, and follow up onchange controls related to manufacturing (bulk/packaging). Manage stakeholders involved.
- Contribute to continuous improvement, including proactively identifying problems, gathering input from the operational team and proposing solutions.
- Participate to or lead projects and initiatives as directed by the Head of manufacturing (bulk/ packaging Operations.
- Act a quality system and GMP Documentation referee for the manufacturing (bulk/packaging Ops Team and as a key Bulk/Packaging team representative for QA Ops.
- Support the Head of Packaging Operations in proactively monitoring Quality and performance metrics and in proposing improvement measures.
- Acts as deputy for the head of Bulk and/or head of Packaging.
Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.
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Bristol Myers Squibb
Boudry
Published: 28 March 2024
Published: 27 March 2024