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Sterile Manufacturing Technical Writer

Location Cork, Ireland

Sterile Manufacturing Technical Writer

The Technical Writer will support the capital project execution, product transfers and operational readiness activities before moving into routine operational support. This facility will contain a state-of-the-art flexible line using isolator technology for filling of vials and syringes and the facility will support both clinical and commercial filling for the majority of the BioMarin biologics product portfolio.

Role Summary

SUMMARY DESCRIPTION

BioMarin has a high-performing, team based organisation, where colleagues are flexible, multi-skilled and empowered to make decisions. A high level of initiative, energy and motivation are key role requirements, as well as excellent organisational and technical writing skills.

As part of establishing sterile filling operations at the Shanbally facility, this role will play an important part in the start-up of the facility including tasks such as; generating technical documentation for example Standard operating procedures, batch record documentation, forms, training documentation etc.

Once start up is complete, the Sterile Manufacturing Technical writer will perform support duties for the sterile manufacturing team. The technical writer will support ongoing GMP documentation review, updates and generation.

This role will involve exercising complete discretion in dealing with confidential information involved in all areas of business.

Role Responsibilities

 Responsibilities will include:

  • Management and prioritisation of drafting, authoring and approval of SOP’s/Forms/ Protocols/batch Records & other documents for various departmental subject matter experts (Manufacturing, Quality, QC, EHS and Engineering) and support the sterile manufacturing process through the change control and document control systems. The role will develop with business requirements.
  • Act as a SME/Superuser on the Controlled Document System to facilitate the processing and approval of documentation.
  • Provide support and guidance to colleagues on systems and ad-hoc queries.
  • Be proactive and collaborative in troubleshooting and resolving issues.
  • Assisting with closure of Deviations/ CAPAs as required.
  • Initiate (& act as responsible person on) Change Requests & attend Change Request Board when required.
  • Assisting with generating and reviewing metrics for example batch record right first time, training and Trackwise.
  • Involvement with audit readiness and self-inspection activities.
  • Involvement with process comparability where required.

Skills

A high level of administrative skills – excellent knowledge of all Microsoft office applications.
High level of organisation, planning and facilitation skills.
Strong customer service focus and proven time management skills.
Very strong interpersonal and communication skills and a strong ability to work in a team environment.
Strong ability to work to tight deadlines.
Strong ability to work on cross functional teams.

Strong ability to prioritise workload
Technical writing with exceptional organizational, spelling, grammar, and typing skills.
Have a flexible approach to adapt to the change in business needs during the start-up of the facility.



Technical:

Technical Knowledge & Expertise
Attention to Detail
Compliance
Documentation
Documentation Management
IT Applications
Organising & Scheduling

Education:
College or University diploma preferred.


Note:     This description is not intended to be all-inclusive or a limitation of the duties of the position.  It is intended to describe the general nature of the job that may include other duties as assumed or assigned.

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

About our location

Cork

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