A career with MilliporeSigma is an ongoing journey of discovery: our 52,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others. MilliporeSigma is a business of Merck KGaA, Darmstadt, Germany.
The Tech positions will be the primary entry point for GMP Manufacturing of biologics at the Carlsbad site. Differentiation on Tech level will be based on experience levels in GMP Manufacturing at both the Carlsbad site and at external locations. These positions do not have supervisory responsibility. Employees will support projects in conjunction with other GMP Manufacturing personnel (Leads, Supervisors, Managers). Employees will have no specific decision-making authority as they are asked to follow GMP batch records. Employees are expected to prepare suites for manufacturing, to document deviations, and to operate in a safe manner for the employee, others in the GMP Manufacturing suites, and for the Product being manufactured.
PURPOSE OF THE POSITION
The Manufacturing Technician in the Operations department is responsible for performing cGMP biopharmaceutical cell culture, buffer and medium preparation, membrane clarification, membrane concentration and buffer exchange, column purification, terminal filtration, Fill and Finish, stocking supplies and raw materials, and cleaning process equipment. They perform all their GMP operations with supervision as necessary. Manufacturing Technicians are progressively developing competency in cGMP manufacturing of biopharmaceuticals and will be trained towards proficiency in all production unit operations.
- Compliance with safety guidelines
Use safety eyewear while inside a manufacturing area
Know appropriate emergency response procedures
Know locations of first aid kits, safety showers, spill kits
Know evacuation route and assembly area to be used in case of fire or earthquake
Know the location of MSDS binders and understand how the guidelines pertain to operations
Follow good chemical safety practices
- Comply with all cGMP Documentation and procedures
Record information accurately
Make corrections in a timely manner
Check all necessary calculations
Review pre-recorded data for accuracy and completion
Ensure all entries are neat and legible
Understand operator and verifier responsibilities
Review labels and equipment calibrations prior to use
Perform preliminary review of completed documentation
Keep logbooks updated and accurate
- Comply with cGMP Practices and Regulations
Generate clear and concise labels for all in-process equipment and materials
Understand, observe, and practice proper gowning
Understand flow of materials and personnel in the manufacturing areas
Maintain clean and well-stocked labs
- Compliance with Policies and Regulations
Compliance with 21 CFR - Parts 210 and 211
Who You Are
- Education: Bachelor of Science degree or equivalent work experience.
- Experience: Minimum of 3 years of directly related experience.
- Essential and Critical Skills:
- Knowledge of biology and chemistry
- Knowledge of relevant unit operations
- Sterile cell Culture
- Disposable bioreactors / viral vector manufacturing
- Disposable clarification / filtration (pharmaceutical unit operations)
- Ultrafiltration / Diafiltration
- Skid operation / column chromatography
- Bulk Drug Formulation and dilution
- Sterile Fill / Finish
- Working knowledge of desktop computers and technical equipment
ADDITIONAL LOCAL NEEDS
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is occasionally exposed to work near moving mechanical parts; fumes or airborne particles; toxic or caustic chemicals; risk of electrical shock and vibration. The noise level in the work environment is usually moderate.
The employee may frequently be required to sit and talk or hear. The employee is occasionally required to stand; walk; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl and taste or smell. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities by this job include close vision, depth perception and ability to adjust focus.
The employee must be able to work off-shifts, weekends, and additional hours as required.
The employee must have the ability to perform moderate physical activity.
The employee must have the ability to perform very complex tasks with attention to detail.
The employee must be self-motivated, work well in a group, and communicate well with all levels of the operations team.
What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!
Curious? Apply and find more information at come2emd.com
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to his/her Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because he/she made a good faith report of discrimination.