Title: Technical Writer II (Scientific)

Location: Swiftwater, PA

Duration: 9+ Months

KEY RESPONSIBILITIES:

• Responsible for designing, developing, and updating required technical documentation; technical writing/editing for all types of documentation produced within a modern software development environment.
• Strong knowledge of word processing software, strong writing and analytical skills to document software capabilities Tracking and reviewing change control documentation.
• Review current documents- incorporate comments from Manager; Navigate through sanofi Geode or similar documentation system utilizing current templates; Notify manager of workflow status and issues; Incorporate comments from team members and provide status to manager on review and approval workflow; Follow up with team members on comments; Complete Annual Audit Trail for PDW and Shop Floor Data and Experience in technical writing in validation environment.
• Support non-conformance issues related to change controls, deviations, corrective Action-Preventative Actions (CAPAs) and memos as needed. Write/revise SOPs and SWIs to align to program strategies under cGMP environment.

SPECIFIC TASKS:

• Support Extractables and Leachables (E&L), Filter Validation, Cleaning and filter validation documentation.
• Participate in Gemba/ shop floor walk through to learn about product processes and / or interview stakeholders to collect data on non-conformance issues.
• Comply with cGMP, health and safety guidelines and other internal and external quality and regulatory guidelines.
• Assist in the technical transfer and industrialization of process from MTECH to the cGMP manufacturing facilities across the site.

OTHER PREFERRED ATTRIBUTES

• Proficient in MS Word, Excel, PowerPoint, database creation and Outlook, Self-motivated and willing to be proactive in resolving issues
• Must possess sound interpersonal and information gathering skills, being able to relate well to others at all levels throughout the organization and have the ability to work in a team environment, effectively interacting with others
• Behaves according to company values and competencies.
• Forward thinking with an attitude of collaboration, optimization, efficiency, continuous improvement.
• Effectively communicates successes, constraints, conflicts, solutions and actions for resolution.
• Proactively resolves conflicts, removes roadblocks to execution within sphere of influence; escalates to functional management when appropriate.
• Fosters relationships with partners and customers in order to achieve technical objectives.
• Strong analytical and technical writing skills, relevant work experience, extensive industry experience in a cGMP/environment is a plus
• Exceptional attention to detail and multi-tasking abilities is a plus

QUALIFICATIONS:

• Adequate experience in industry to perform the required tasks, or a Bachelor's degree in Chemistry/Biochemistry/Biological Science/other science degree with 0-3 years, or Master’s degree in Chemistry/Biochemistry/Biological Science with 0-1 + years.

TechData is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status.

Job Type: Contract

Pay: Up to $42.00 per hour

Benefits:

• Dental insurance
• Health insurance

Schedule:

• 8 hour shift

Education:

• Bachelor's (Required)

Experience:

• cGMP manufacturing: 2 years (Required)
• Chemistry/Biochemistry/Biological Science/other science: 3 years (Required)
• cGMP guidlines: 3 years (Required)

Work Location: One location

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