Technical Operations Specialist in Burlington, MA

Date Posted: 07/21/2020

Job Snapshot

Job Description

Description

AMRI provides global contract research and manufacturing services to the pharmaceutical and biotechnology industries. The Technical Operations Specialist will assume responsibility for internally overseeing the manufacture and completion of client project activities to support release of products for clinical trials and ensure the delivery of batch manufacture and documentation to GMP standards, in line with client project timelines. The job holder will also be required to liaise, guide and develop the wider production team to ensure continuous development and successful delivery of projects. Join our talented workforce, where a commitment to excellence and a customer focused attitude is everything. We pursue excellence because our work has the power to improve patients’ lives with the pharmaceuticals we develop and manufacture. Responsibilities
• Develop batch records for client-specific formulation and filling operations
• Perform processing operations including equipment preparation, bulk product formulation, sterile filtration, and filling support to facilitate process design and internal technology transfer
• Identify and specify process specific equipment needed for client tech transfer, developing techniques and process parameters specific to the clients’ product while maintaining critical product attributes
• Assist in authoring instructions for the operation of equipment and for detailing process flows in clean room facility
• Responsible for maintaining 100% trained on applicable curricula
• Understands and follows OSHA, HAZOP, and AMRI procedures and guidelines when handling or disposing of hazardous materials and maintaining overall safety culture
• Performs hazardous waste handling operations in accordance with AMRI procedures
• Provide guidance to junior team members 
• Creates formulas, recipes, batches, and completes batch consumption in Oracle

Qualifications


• Bachelors of Science Degree in Biology, Chemical Engineering, or related field
• 3-5 years’ experience in a cGMP, sterile manufacturing environment
• Meticulous and highly organized
• Aseptic technique, familiarity with clean room personnel flows is desirable
• Computer literate with good working knowledge of spreadsheet software (Visio or equivalent drawing programs a plus)
• Familiarity and understanding of cGMP’s in a accordance with 21CFR210, and 21CFR211
• Knowledge and understanding of the principles associated with aseptic filling technology (e.g. rotary piston/positive displacement pump, peristaltic pump systems) Physical Demands While performing the duties of this job, the employee is regularly required to sit; use hands to finger, handle, or feel; and talk or hear.  The employee frequently is required to reach with hands and arms.  The employee is occasionally required to stand; walk; climb or balance;and stoop, kneel, crouch, or crawl.  The employee must occasionally lift and/or move up to 50 pounds.  Specific vision abilities required by this job include close vision, and ability to adjust focus. Work Environment While performing the duties of this job, the employee has the potential of being exposed to fumes or airborne particles and toxic or caustic chemicals (wearing proper Personal Protective Equipment will be required in these situations).  The employee is occasionally exposed to wet and/or humid conditions; moving mechanical parts; high, precarious places; outside weather conditions; and may be expected to work with electronic equipment (always being aware of one’s environment and taking proper precautions is required).  The noise level in the work environment is usually moderate.  Employee may be responsible for moving and/or generating hazardous waste for treatment, storage and disposal. Affected employee will need to be familiar with the applicable training requirements included in the customized Resources, Conservation and Recovery Act. Employee will understand waste labeling, secondary containment, chemical compatibility, storage time limits, container size and quantity limits, container integrity when waste is left unattended and improper disposal of hazardous materials. 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. All interested applicants must apply online. AMRI is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Job: Manufacturing
Primary Location: Burlington, Massachusetts
Schedule: Full-time
Job Posting: 07/21/2020
Shift Type:

AMRI is an Equal Opportunity Employer.  All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

EEO is the Law (English / Español) / EEO Supplement / Pay Transparency