Manufacturing Technician
2 weeks ago
Title: Manufacturing Technician
Location: Exton, PA (onsite)
Full-time
Frontage Laboratories Inc. is an award winning, full-service, CRO/Contract Research Organization operating over 25 state-of-the-art laboratories across the US, Canada and China. Our core competencies include drug metabolism, pharmacokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, and core laboratory services for clinical trials.
Position Summary:
Responsible for maintaining GMP Cleanrooms, equipment, performing manufacturing procedures and executing diverse tasks in various clinical trial material processing areas. Follows cGMP requirements as well as policies and procedures of the business.
The ideal candidate will have working experience in a regulated pharma or biotech environment (GMP, SOPs, Cleanroom and Equipment Maintenance etc.).
Position Responsibilities:
- Participate in cleaning and set up of equipment and clean/disinfect cleanrooms rooms as necessary. Monitor and record readings of equipment and systems.
- Executes and monitors manufacturing processes according to operational procedures.
- Verifies parameters to ensure CGMP and GLP compliance.
- Takes samples and performs tests during process according to standard procedures.
- Participates in projects focused on process development and/or improvement, cost controls and new product manufacturing.
- Troubleshoots equipment issues. Performs equipment maintenance, conditioning, standardization, and calibration as needed.
- Handles, stores, and disposes of hazardous and nonhazardous materials incompliance with company policy and regulatory requirements.
- Handles chemicals appropriately using required safety equipment. Participates in the execution of validation/revalidation protocols.
- Individuals with sterile work environment, buffer formulation, aseptic cleanroom operations experience is a preference.
- Candidates will also be required to gown up, so they need to be screened for their comfort with gowning.
- Perform tasks assigned by his/her manager per procedures and practices compliant with cGMP.
- Perform moderate to high complexity pharmaceutical processing and testing procedures.
- Meet the quality and quantity production and testing goals established by the department and appropriately manage any exceptions.
- High School Diploma, Technical, or Associate degrees is required.
- 1+ years of experience in the pharma, chemical, biotech industry or related field
- Must be able to read, understand, and follow the company's SOP's, policies and practices.
- Ability to perform physical duties including lifting and carrying up to 50 lbs. / Walking, standing, bending, stooping
- Potential exposure to particulates, vapors or noisy environment. Must be able to wear a Respirator or Dust Mask.
- Experience with cGMP guidelines.
Salary and Benefits:
Frontage Laboratories offers a competitive compensation and benefits package including health and dental insurance, a 401(k) plan, disability insurance, and life insurance.
Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability.
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