Senior Engineer Manufacturing
vor 2 Wochen
Working with Us
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.
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.
Position Summary
- The Senior Engineer Manufacturing & Compliance authors, owns and leads updates of GMP documents/projects related to Bulk Operations.
- He/she initiates and owns deviations assessments and participates in investigation tasks as required.
- He/she supports the Head of Bulk Operations in monitoring quality and performance metrics and acts as a referee for the operational team for GMP systems, documentation, and training.
- He/She supports and leads projects with the GMP activities (change control, URS, Protocol, etc…)
Duties/Responsibilities
- Initiate deviations and participate in on-the-floor investigations. Partner with QA and Boudry Bulk Operations to ensure assessments are exhaustive.
- Follow up and implement assigned CAPAs.
- Author and review manufacturing documents, including specifications, working practices, SOPs, 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 or Support manufacturing projects (new equipment, process change, etc…) by managing the documentation associated with the project (URS, Protocol, Change Control, etc…)
- Lead risk assessments, data integrity risk assessment and risk management within cross-functional teams (from draft to approval).
- Maintain all risk assessments up to date.
- Perform complaint investigations.
- Manage the defect library process and the related training for the site.
- Initiate, own, and follow up change controls related to manufacturing (bulk). Manage stakeholders involved.
- Ensure distribution and withdrawal of GMP documents in manufacturing area.
- Contribute to continuous improvement, including proactively identifying problems, gathering input from the operational team and proposing solutions.
- Participate in or lead projects and initiatives as directed by the Bulk Operations management.
- Act as quality system and GMP Documentation referee for the Manufacturing Bulk Ops Team and as a key representative for QA Ops.
- Support the team in proactively monitoring quality, safety and performance/reporting metrics (OEE, Tier Meeting) and in proposing improvement measures.
- Act as the backup of other Engineer Manufacturing & Compliance within the manufacturing department.
Reporting Relationship
This position reports to the Bulk Head.
Qualifications
- BS/MS in Engineering/Technical discipline or equivalent experience.
- 7 years’ experience in pharmaceutical validation, packaging, drug manufacturing process 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 especially in Oral Solid Dosage form (OSD).
- 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.
- Fluent in English and in French.
If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
On-site Protocol
BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
- Site-essential roles require 100% of shifts onsite at your assigned facility.
- Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility.
- For field-based and remote-by-design roles, the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
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