Manufacturing Associate III – Parenteral Filling (Nights)
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Job Location:
Durham County, NC - USA
Monthly Salary:
$ 25 - 34
Posted on:
3 hours ago
Vacancies:
1 Vacancy
Job Summary
About This Role
Our factories run 24/7 operations. Our manufacturing teams work 12-hour shifts (either Days or Nights) on a 2-2-3 calendar rotation.
Shift Details:
- 12-hour shifts
- Nights: 6:00 PM 6:00 AM
- Rotating 2-2-3 schedule
Our Manufacturing Associates perform processing steps and manufacturing support activities in our Drug Product (Parenteral Filling) facility in Research Triangle Park (RTP). These teams are the backbone of our operationseach playing a critical role in delivering life-changing therapies to the patients who need them.
Our teams are organized by key steps in the biomanufacturing process. Parenteral Filling Manufacturing Associates execute critical aseptic operations in a controlled cleanroom environment governed by Current Good Manufacturing Practices (cGMP).
What Youll Do
- Parenteral Filling Operations Include
- Aseptic filling of drug product into vials syringes or cartridges
- Operation of automated and semi-automated filling lines
- Component preparation setup and changeover activities
- Environmental monitoring and in-process controls
- Visual inspection and bulk handling activities as applicable
- Execute daily manufacturing activities including operating process equipment and executing validation protocols in accordance with cGMP Standard Operating Procedures (SOPs).
- Accurately document and record all cGMP data and information including deviations for processing steps and equipment activities. Create and revise key documentation such as batch records SLRs and equipment logbooks.
- Assist with in-process sampling and basic analytical testing as required.
- Maintain a clean safe and compliant work environment with a strong focus on inspection and audit readiness.
- Collaborate effectively as a team member and demonstrate leadership through engagement accountability and operational excellence.
- Actively participate in and support training and development initiatives for both personal growth and the development of team members.
Who You Are
Youre driven by a mission to save lives and bring a deep sense of purpose to the work you do. Biomanufacturing is complex and you thrive in fast-paced environments where learning agility problem-solving and adaptability are essential.
Required Skills
- The following combinations of education and direct experience will be considered:
- Bachelors degree in Science Technology Engineering or Mathematics (STEM) or a related field from an accredited college or university with a minimum of .5 years of direct experience
- BioWorks Certificate or associates degree in Science Technology Engineering or Mathematics (STEM) or related field from an accredited institution with a minimum of 1 year of direct experience
- High school diploma or equivalent with a minimum of 1.5 years of direct experience
- Demonstrated experience working in a cGMP manufacturing environment
- Strong documentation compliance and process execution skills
- Ability to lead tasks support teams and collaborate effectively across shifts
Preferred Skills
- Prior Parenteral Filling experience
- Experience with TrackWise DeltaV and LIMS systems
Additional Information
Base salary offered is determined through an analytical approach utilizing a combination of factors including but not limited to relevant skills & experience job location and internal equity.
Regular employees are eligible to receive both short term and long-term incentives including cash bonus and equity incentive opportunities designed to reward recent achievements and recognize your future potential based on individual business unit and company performance.
In addition to compensation Biogen offers a full and highly competitive range of benefits designed to support our employees and their families physical financial emotional and social well-being; including but not limited to:
- Medical Dental Vision & Life insurances
- Fitness & Wellness programs including a fitness reimbursement
- Short- and Long-Term Disability insurance
- A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
- Up to 12 company paid holidays 3 paid days off for Personal Significance
- 80 hours of sick time per calendar year
- Paid Maternity and Parental Leave benefit
- 401(k) program participation with company matched contributions
- Employee stock purchase plan
- Tuition reimbursement of up to $10000 per calendar year
- Employee Resource Groups participation
Why Biogen
We are a global team with a commitment to excellence and a pioneering spirit. As a mid-sized biotechnology company we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning growth and expanding their skills. Above all we work together to deliver life-changing medicines with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.
At Biogen we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds cultures and perspectives make us a stronger and more innovative company and we are focused on building teams where every employee feels empowered and inspired.Read onto learn more about our DE&I efforts.
All qualified applicants will receive consideration for employment without regard to sex gender identity or expression sexual orientation marital status race color national origin ancestry ethnicity religion age veteran status disability genetic information or any other basis protected by federal state or local law. Biogen is an E-Verify Employer in the United States.
Required Experience:
IC
Key Skills
- Lean Manufacturing
- Six Sigma
- Continuous Improvement
- ISO 9001
- Lean Six Sigma
- Management Experience
- Manufacturing & Controls
- 5S
- Manufacturing Management
- Kaizen
- Chemistry
- Manufacturing
About Company
Founded in 1978, Biogen is a leading biotechnology company that pioneers innovative science to deliver new medicines to transform patients lives and to create value for shareholders and our communities. We apply deep understanding of human biology and leverage different modalities, ... View more
