PDS Tech is seeking candidates for a Manufacturing Associate in Cambridge, MA
How will you make an impact?
The Manufacturing Associate is an associate with little to moderate level of technical expertise and experience. An Associate may independently perform routine operations commensurate with their experience and training. An Associate participates in the day to day operation of a cGMP compliant Manufacturing facility.
What will you do?
- Responsibilities include performing basic to moderately complex activities related to operating bioprocess manufacturing equipment, completing the associated documentation of those activities, monitoring assigned processes using automated production systems and controls.
- Other activities include keeping the GMP manufacturing facility in a state of inspection readiness, using performance tools (Human Performance), and routine housekeeping activities.
- The Associate must be technically capable with a basic theoretical comprehension of general biopharmaceutical manufacturing equipment, principles and processes and have a basic understanding of current GMP and safety standards
- 12 hour rotating day shift from 7am-7pm, 2 days on, 2 days off, and rotating weekends. May require overtime to work evenings, weekends or holidays, as required to meet project timelines.
How will you get here?
- Must be able to make decisions for moderately complex GMP manufacturing activities including process performance with minimal to moderate supervision.
- Must be able to recognize, understand and respond to situations requiring further evaluation and report these events (process, safety, personnel, etc..) to senior operators or area management.
- Must be able to provide effective written or verbal communication to peers, senior associates, and area management within their operational group
- Must be able to understand operational documents for GMP compliance, accuracy and completeness.
- Must safely perform activities on the shift in order to prevent releases, accidents and injuries.
Education and Qualifications:
- Bachelor’s Degree in Life Sciences or
0-3 years’ industry related experience with a Bachelor’s Degree in Life Sciences
1-3 years’ industry related experience with a Associates Degree/certificate program
2-4 years industry related experience with a high school diploma
- Strong interpersonal and communications skills; written and oral.
- Solid understanding of applicable regulatory requirements.
- Ability to function in a dynamic environment and balance multiple priorities simultaneously
- Ability to learn new software and tools quickly.
- Ability to make decisions and work with minimal to moderate supervision.
- Ability to aseptically gown and/or sterile gown as needed.
- While performing the duties of this job, the employee is required to write, read/review written documentation for extended periods of time. Specific vision requirements for this job include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus.
- Is regularly required to talk and hear. The employee frequently is required to sit and stand for extended periods. The employee is occasionally required to lift, stand; walk; use hands to finger, handle, or feel; reach with hands and arms; and stoop, kneel, or crouch.