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Automation and Engineering Compliance
Leading Pharmaceutical Company
High Growth Organization
About Our Client
High growth company. Since 2014 they have increased their employee headcount from 3,000 to 5,700. A new facility has been complete, additional warehouse building under construction, and purchased an additional building within the area.
Essential Duties and Responsibilities include, but are not limited to, the following:
- Provide support, information, and assistance to individuals, groups and management with the initiation, authorship, review, submission, and follow-up/completion of documents such as Change Controls, EOE's, NOE's, DNF's, risk assessments, impact statements and corrective/prevention action plans. Participate/lead/author investigations and root cause analysis for department issues of non-compliance.
- Act as a liaison between Engineering & Automation and onsite quality and regulatory groups to define and address compliance related items.
- Participate in authorship of responses, and track/trend results of department quality and regulatory audits/inspections.
- Provide tracking and trending for maintenance of related compliance activities i.e. quality instances and PERs.
- Maintain knowledge of current good manufacturing practices (cGMPs), Biotech/Pharmaceutical industry guidance/emerging draft guides, etc. and conduct department relevant evaluations against these documents.
- Identify opportunities for continuous improvement of compliance and lead improvement initiatives.
- Provide periodic review of department documentation and records such as Periodic Evaluation Reports (PER), logbooks, preventative maintenance records/work orders, etc. to assess for compliance with established quality standards, policies and procedures. Instruct/council department members in proper execution.
- Facilitate reviews and revisions of Department related SOP's, life cycle documents, plans and policies for each group within the Department.
- Specify and coordinate training, OJT/ILC and SOP, for Automation, Engineering and contracted personnel. Knowledge and Skills:
Knowledge and Skills
- Current knowledge of cGMP biotech/pharma operations, regulatory and quality policies, procedures and documentation methods.
- Strong knowledge of Design Lifecycle and Quality Risk Management
- Must work independently and have project management capabilities.
- Knowledge of biotech/pharma manufacturing process/supporting laboratory testing and regulatory requirements, related terminology and jargon commonly used in association with daily operations of a facility and the ability to use the terminology, in context, when discussing issues or generating documentation.
- Strong leadership capabilities and organizational skills.
- Ability to speak to large groups of people (including senior management and regulatory agencies).
- Excellent writing, communication and interpersonal skills.
- Working knowledge of word processing, spreadsheet, PowerPoint and database management software.
The Successful Applicant
Requires BA/BS (engineering, scientific or related field preferred) and 3+ years of related experience working in a cGMP environment or in the operation of a relevant industrial facility.
What's on Offer
Competitive salary, bonus, and excellent relocation package