Engineer II/III, Label and Packaging - United States
- The Engineer II/III, GMS Label & Pack, supports the Packaging, Labeling, and Serialization operations from a Manufacturing Science perspective and assists the manufacturing operations with all technical process related aspects of packaging and labeling operations at contract manufacturers and internal facilities.
- He/She provides Technical support services to US teams responsible for projects typically aligned with new, existing, and post-commercial, product development efforts at our company.
- This includes interfacing with satellite groups, on behalf of GMS, to ensure timely responses and delivery of project deliverables in accordance with our company's project requirements.
- Technical Support Services may be in the form of, but not limited to, documentation review; documentation prep; new documentation creation (e.g. Forms, PVPP’s, PVPR’s, Final Reports, URS’s, Technical assessments, etc.), monitoring of qualification/validation activities at CMO’s; troubleshooting of process related issues at the CMO’s; and routine project support for items such as task lists, schedules, updates, etc.
- Conducts/participates Label and Pack process related investigations as a results of deviations and/or customer complaints,
- Attend Project based team meetings representing GMS Label and Pack department,
- Review/Comment/Prepare documents that may be relevant to Label and Pack Tech Transfer Projects
- Monitor Label and Pack Process validation activities,
- Participates process optimization efforts at internal and/or external sites
- Works closely with other team members from the Supply Chain, External Manufacturing, Quality, Development, and Manufacturing to execute against corporate objectives and functional goals.
- Other duties as assigned.
- Possess technical knowledge regarding pharmaceutical/biopharmaceutical label and packaging operations.
- Demonstrated strong oral and written communication skills; ability to communicate with management, peers and subordinates effectively
- Strong organizational and project management skills;
- Ability to multi-task and coordinate multiple activities in parallel
- Demonstrated problem solving skills
- Demonstrated instrument/computer system troubleshooting skills
- Knowledge of FDA/EMEA regulations including 21CFR parts 210/211 (GMP), EudraLex Vol. 4 (EU GMP), 21CFR Part 11, Annex 11 PREFERRED
- Knowledge of qualification and validation and familiarity with: Validation Plans, Risk Assessments, User Requirements/Design Specifications, IQ/OQ/PQ Protocols, Reports, and Standard Operating Procedures (SOPs)
- Master’s degree in Life Science, Computer Science or Engineering with a minimum of 3 to 5 years relevant experience
- Bachelor’s degree preferred in Life Science, Computer Science or Engineering with a minimum of 5 to 7 years relevant experience OR
- Associate’s degree required with at least 12 years relevant experience.
- Through cutting-edge science and medicine, our company discovers, develops and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases.
- Our company is a pioneer in biotechnology and today the Company has the leading portfolio of medicines to treat multiple sclerosis (MS), has introduced the first and only approved treatment for spinal muscular atrophy, and is at the forefront of neurology research for conditions including Alzheimer’s disease, Parkinson’s disease and amyotrophic lateral sclerosis (ALS).
- Our company also manufactures and commercializes biosimilars of advanced biologics.
- Our global organization of nearly 7,000 employees is committed to a single mission: making a meaningful difference in the lives of patients with few or no treatment options.
- Our company was founded in 1978 and today serves patients in nearly 70 countries.
- We aspire to have the greatest impact on patients and science of any biotechnology company in the history of our industry.
- To us, that means creating novel medicines that benefit individuals and society, and bringing new scientific understanding to diseases for which there are no adequate treatments.
- For nearly two decades our company has led in the research and development of new therapies to treat MS, including the most prescribed oral treatment in the world.
- Now our research is driving revolutionary new MS treatments with the goal of reversing or even repairing damage caused by the disease.
- We are now applying our neurological expertise to solve some of most challenging and complex diseases of the brain, including Alzheimer’s disease, Parkinson’s disease, and ALS.
- As we uncover new insights into human biology, our company is employing cutting-edge technologies to discover potential treatments for rare and genetic disorders.
- Our company is revolutionizing biologic manufacturing, developing the industry’s most advanced plants and processes.
- This expertise is used to produce both original innovative therapies and bio similar that expand patient access to lower-cost medicines.
Our Corporate Citizenship
- The same intellectual discipline and passion that drives our science is reflected in our corporate citizenship, environmental sustainability, and commitment to diversity and inclusion.
- As a company, we are focused on improving science education and limiting the impact of our company on the environment.
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