COMPANY OVERVIEW
Halo Pharmaceutical is a technology-focused contract development and manufacturing organization (CDMO) specializing in solid, semi-solid, and liquid dosage forms, with differentiated expertise in controlled substances manufacturing. With facilities in the United States and Canada, Halo supports leading pharmaceutical companies through high-quality manufacturing, operational excellence, and customer-focused solutions.
Join a growing CDMO where your leadership, operational expertise, and ability to drive performance will directly influence site success and customer satisfaction.
POSITION OVERVIEW
Halo Pharmaceutical is launching a new sterile injectable manufacturing suite (operational 2026) supporting vial, syringe, and cartridge filling on the Groninger UFVN FlexFill line within a SKAN isolator environment. The Technical Writer, Sterile Operations will develop, revise, and maintain the documentation backbone for this facility – including Standard Operating Procedures (SOPs), forms (FRMs), Master Batch Records (MBRs), and supporting logs – covering the full sterile process flow: bulk, sterile filtration and filter integrity testing, sterile filling, VHP decontamination, parts washing, autoclaving, and facility cleaning/environmental monitoring (ISO 5/7/8). This role also provides direct writing support to Operations and Quality during deviation investigations, ensuring documentation is clear, technically accurate, inspection-ready, and aligned with cGMP and applicable DEA-adjacent controlled-space requirements.
KEY RESPONSIBILITIES
Author, revise, and format SOPs and associated forms (FRMs) for sterile operations, including bulk formulation, sterile filtration, aseptic filling, VHP decontamination, parts washing/autoclaving, and cleaning/environmental monitoring.
Translate input from Operations, Validation, Quality, and Engineering SMEs into clear, step-by-step, inspection-ready procedures consistent with cGMP and site document control standards.
Manage document lifecycle (new, revision, periodic review, retirement) and control multiple concurrent revisions while preserving accuracy of source content and integrated changes.
Edit, standardize, and harmonize documentation prepared by other authors or SMEs for consistent terminology, style, and formatting across the sterile facility document set.
Batch Record Authoring
- Develop and maintain detailed Master Batch Records (MBRs) and Master Packaging/Batch Records (PBRs) for sterile drug product, based on complex technical input from Product Development, Operations, Validation, and Quality.
- Ensure batch records accurately reflect approved processes, equipment, in-process controls, and critical process parameters.
- Maintain revision control and traceability for batch records, incorporating specific, requested changes from Operations, Validation, and Quality with full accuracy of original content.
- Support review of executed batch records for documentation clarity and completeness ahead of QA release.
Investigation Support
- Provide direct writing and documentation support for deviation investigations, discrepancies, and CAPA records originating from sterile operations, in collaboration with Operations and Quality Assurance.
- Assist in drafting clear, thorough, and well-organized investigation narratives, background/scope sections, and corrective/preventive action documentation using site investigation tools and quality risk management principles.
- Collaborate with SMEs and QA to capture root cause analysis, impact assessments, and lessons learned in accurate, audit-ready written form.
- Support trending and documentation needs related to recurring deviations, environmental monitoring excursions, and equipment/utility events specific to the sterile suite.
Position Qualifications
- Accuracy – Ability to perform detailed technical writing work accurately and thoroughly.
- Regulatory/GMP Knowledge – Working knowledge of cGMPs and sterile/aseptic manufacturing concepts sufficient to write and review technical documentation.
- Adaptability – Ability to adapt to a new facility start-up environment with evolving procedures and priorities.
- Communication – Strong technical writing and editing skills; ability to translate complex, technical, or scientific input into clear, concise procedures and records.
- Detail Oriented – Ability to identify and correct minute inconsistencies in records, forms, and batch documentation.
- Organized – Self-motivated, systematic approach to managing multiple documents, revisions, and deadlines.
- Investigation Writing – Ability to write clear, logical investigation narratives and support root cause/CAPA documentation.
- Collaboration – Ability to build effective working relationships with Operations, Validation, Quality, and Engineering SMEs.
- Proficiency in Microsoft Word and Excel; experience with electronic document management systems (e.g., Master Control) and quality/investigation systems (e.g., TrackWise) preferred.
- May be required to move about the sterile facility and gown/degown per site procedures.
- Must be able to remain sedentary for periods of time.
- May be required to wear personal protective equipment, including cleanroom garb, in classified areas.
EDUCATION:
Bachelor’s degree (four-year college or university) in a scientific, engineering, or related technical discipline; equivalent industry experience considered in lieu of degree.
EXPERIENCE:
- Two to five years of related experience, preferably in pharmaceutical or sterile/aseptic manufacturing.
- Experience in batch record preparation, SOP authoring, and technical report writing in a cGMP environment.
- Experience supporting or writing deviation investigations, RCA, and CAPA documentation strongly preferred.
- Familiarity with sterile/aseptic processing concepts (isolator technology, VHP decontamination, aseptic filling, environmental monitoring) a plus.
- Experience with quality/investigation tracking systems (e.g., TrackWise) preferred.
Halo Pharma provides a pay range for this role in accordance with applicable pay transparency laws. Individual pay rates are determined by assessing expertise, skills, education, and professional background.
Halo is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.
Job Type: Full-time
Pay: $50.00 per hour
Work Location: In person
