Manufacturing Tech I

Company: Smith & Nephew
Location: Columbia
Posted on: January 16, 2022

Job Description:

Summary of Position

Responsible for hands-on execution of all activities in the manufacturing area including the processing and packaging of human tissue products for transplantation. All duties are performed in compliance with FDA cGMP/cGTP requirements, American Association of Tissue Banks (AATB) standards, and Osiris Therapeutics Inc. standard operating procedures (SOPs). The candidate should have a commitment to high standards of quality

Responsibilities/Job Duties

* Follow batch production records (BPRs) and SOPs to manufacture human tissue products.
* Utilize good documentation practices.
* Assist in the preparation of reports and other documentation as applicable to the scope of operations in the manufacturing facility.
* Identify areas for improvement in manufacturing efficiencies and compliance.
* Assist with technology transfer from R&D to manufacturing environment.
* Perform cleaning and preparation of all equipment necessary for the daily manufacturing of products.
* Conduct training sessions for less experienced technicians to ensure a high level of effectiveness and quality is met during production operations.
* Maintain appropriate inventories of supplies within the production area.
* Become an expert in selected key areas of interest.
* Perform housekeeping and general upkeep throughout the production area as required

Operational Competencies

* Ability to interact professionally at multiple levels
* Excellent organizational, written, and verbal communication skills
* Ability to manage multiple tasks and prioritize workload
* Ability to work professionally with highly confidential information
* Flexibility and ability to adjust to changing priorities and unforeseen events; excellent time management skills
* Ability to work consistently in a fast-paced environment
* Able to handle high pressure situations and constructively resolve potential conflicts

Education and Training/Certification

Required:

* Associates degree in a life science
* 1 - 2 years of relevant experience in a GMP environment
* Additional GMP experience may be substituted for educational experience.

Preferred:

* Bachelor's degree in a life science

Related Work Experience

* Familiar with aseptic technique
* Ability to perform mathematical calculations
* Strong interpersonal skills and the ability to work effectively and efficiently in a team environment.
* Excellent oral and written communication skills.
* Ability to work flexible hours including overtime and weekends.

Material & Equipment Used & Frequency

* Computer - Daily
* Autoclave - Daily
* Heat Sealers - Daily
* Lyophilizer - Weekly

Work Environment / Travel Requirements

* Office Environment
* Cleanroom Environment
* Laboratory Environment
* 0% Travel

Physical Requirements

* Must be able to stand for up to 4 hours at a time
* Must be able to remain in PPE in a cleanroom environment for up to 8 hours.
* Must be able to lift 30 pounds repeatedly
* Must have manual dexterity sufficient to cut finely with a scalpel

DISCLAIMER:

A job description is only to be used as a summary of the major functions performed by a position and therefore may not capture every responsibility or duty.

Smith+Nephew provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability.

Keywords: Smith & Nephew, Baltimore , Manufacturing Tech I, Other , Columbia, Maryland