Validation/ Technical Writer

Duration: 12+ month

Location: Andover, MA

Top 3 critical skills:

· Strong working knowledge of the validation lifecycle including computer system validation, 21 CFR Parts 210 and 211, and Part 11, Electronic Records and Electronic Signatures.

· Working knowledge of data integrity regulations, guidance, and principles

· Strong technical writing skills

Minimum education experience required: BS in Scientific discipline

Years of experience required: 3-5 years

Job Description:

This role will provide support to the QC Analytical and Microbiology departments for QC instrument data integrity assessments and remediation activities. This scope includes QC Instruments (both portable and computer-controlled), paper-based systems, and local instances of enterprise system data management. Systems and processes within scope will require assessment via company's pre-established criteria in order to identify gaps against company data integrity expectations. The candidate will be responsible for executing or facilitating execution of these gap assessments through collaboration with laboratory subject matter experts (SMEs) at company. Upon completion of gap assessments, the candidate will be responsible for leveraging the results as follows:

• Facilitating, proposing, and/or assembling gap closure recommendations, through collaboration with SMEs

• Summarizing results from their assessments into reports utilizing a supplied format

• Authoring Corrective & Preventive Action plans (CAPAs) for systems with long-term remediation activities, and authoring final reports for systems with short term/completed remediations

• Managing all gap assessment and remediation reports through company review and approval workflows

• Performing supporting remediation work in the form of SOP revisions as well as authoring and executing change controls and validation test plans/protocols when required per remediation plans

Additional Skills:

Successful candidate requires:

• Strong working knowledge of the validation lifecycle including computer system validation, 21 CFR Parts 210 and 211, and Part 11, Electronic Records and Electronic Signatures.

• Working knowledge of data integrity regulations, guidance, and principles

• Working knowledge of CAPA and change control processes

• Strong technical writing skills

• Strong interpersonal, oral and written communication skills as there is a high degree of collaboration required between members of QC, QA Validation, Instrument Validation, and IS/IT functions.

• A detail-oriented approach to deliverables as the main job responsibility is generation, review, and approval of GMP documentation.

• A BS degree in science, engineering, computer science, or related technical discipline with minimum 2-3 years pharmaceutical/biopharmaceutical experience in a relevant GMP role (validation, quality control, quality assurance, IS/IT compliance, etc.)

Past experience working with QC instrumentation in the biopharmaceutical field is preferred but not required.

• Strong working knowledge of the validation lifecycle including computer system validation, 21 CFR Parts 210 and 211, and Part 11, Electronic Records and Electronic Signatures.

• Working knowledge of data integrity regulations, guidance, and principles

• Working knowledge of CAPA and change control processes

• Strong technical writing skills

•Strong interpersonal, oral and written communication skills as there isa high degree of collaboration required between members of QC, QA Validation, Instrument Validation, and IS/IT functions.

•A detail-oriented approach to deliverables as the main job responsibility is generation, review, and approval of GMP documentation.

•A BS degree in science, engineering, computer science, or related technical discipline with minimum 2-3 years pharmaceutical/biopharmaceutical experience in a relevant GMP role (validation, quality control, quality assurance, IS/IT compliance, etc.) Past experience working with QC instrumentation in the biopharmaceutical field is preferred but not required.

All your information will be kept confidential according to EEO guidelines.