Technical Writer II - Technical Operations (Fixed Term)

at  Thermo Fisher Scientific

Mississauga, ON, Canada -

Start DateExpiry DateSalaryPosted OnExperienceSkillsTelecommuteSponsor Visa
Immediate29 Dec, 2024Not Specified04 Oct, 20243 year(s) or aboveBatch Records,Manufacturing,Gloves,Communication Skills,Equipment Operation,Training,PackagingNoNo
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Description:

JOB DESCRIPTION

Business Title: Technical Writer II – Technical Operations (Fixed Term)

SUMMARY:

Prepare and revise master batch records (MBRs) for manufacturing and packaging and provides input, supports and assistances the Technical Operations, Pharmaceutics & Process Technology (PPT) and Operations groups. Assist with maintaining up to date MBR templates and completes improvement projects related to technical writing.

EDUCATION:

College Diploma in Science/Technical related field.

EXPERIENCE:

Minimum 3 years related experience. Preferred experience: batch records, or, manufacturing or packaging.
Equivalency:
Equivalent combinations of education, training, and relevant work experience may be considered.

KNOWLEDGE, SKILLS AND ABILITIES:

Strong written and oral communication skills. Must be well organized and detail oriented. Ablity to to lead improvement projects. Knowledge of Good Manufacturing Practices and ability to follow Standard Operating Procedures (SOPs). Ability to work under pressure and meet tight deadlines. Proficiency with Microsoft Office applications. Proficiency with the English Language.

PHYSICAL REQUIREMENTS:

Light physical effort and fatigue. Walks, sits or stands for limited periods. May require occasional equipment operation including keyboard equipment. Lifts light items for limited duration. Typically located in a comfortable indoor area. There may be exposure to mild physical discomfort from factors such as dust, fumes or odours, temperature utmosts, loud noise, strong drafts, or bright lights. Use of Personal Protective equipment may be required and may include any of the following: safety glasses, safety shoes, lab coat, gloves, hair net, beard cover, safety apron, respirator occasionally.

Responsibilities:

  • Work closely with the Technical Operations, PPT Engineers and commercial departments in the generation and approval of work orders.
  • Work with internal teams addresses client comments
  • Generate and develop all master batch records used in Good Manufacturing Practices environment.
  • Work closely with Engineers, Business and Project Managers to understand requirements for each MBR.
  • Attend key project team meetings, client teleconferences and on-site visits.
  • Create change controls (af required).
  • Assist Technical Operations and PPT group as required.
  • May be required to assist with report generation from Systems, Applications and Products (SAP).
  • Update and maintain MBR templates to comply with current practices in Operations and PPT
  • Maintain a safe working environment and reports potential hazards.
  • Perform alternating or rotating shift work (as required)


REQUIREMENT SUMMARY

Min:3.0Max:8.0 year(s)

Pharmaceuticals

Production / Maintenance / Quality

Clinical Pharmacy

Diploma

Proficient

1

Mississauga, ON, Canada