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Manufacturing Sciences Technical Writer III

The Fountain Group LLC

Morrisville, NC

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JOB DETAILS
SALARY
SKILLS
Asepsis, Biochemistry, Biology, Biotech and Pharmaceutical, Campaigns, Change Control, Chemical Engineering, Chemistry, Clinical Study Publications, Clinical Support, Current Good Manufacturing Practice (cGMP), Data Sets, Documentation, Drug Manufacturing, Drug Products, Environmental Sciences, FDA (Food and Drug Administration), GMP (Good Manufacturing Practices), ICH Regulations, Insurance Regulations, Investigative Reports, Manufacturing, Manufacturing Operations, Manufacturing Requirements, Manufacturing Technology, Manufacturing/Industrial Processes, Operations Processes, Process Development, Process Validation, Quality Assurance, Realtime Transport Protocol, Regulations, Regulatory Reports, Regulatory Submissions, Support Documentation, Team Player, Technical Operations, Technical Support, Technical Writing, Traceability, Validation Documentation, Writing Skills
LOCATION
Morrisville, NC
POSTED
1 day ago
Details for the position are as follows:
  • 6-month contract to start with the possibility of extension or conversion depending on performance and business needs
  • Rate: $63.69 an hour
  • Location: Morrisville, NC -100% onsite
Job Description:
  • As a member of the Manufacturing Sciences team, the Technical Writer will provide documentation support for clinical and commercial manufacturing campaigns at the RTP Parenteral Manufacturing Facility. This role serves as a key contributor to investigations, process qualification activities, and project implementation efforts by leveraging technical expertise in fill/finish operations, visual inspection, and packaging processes.
  • The Technical Writer will be responsible for authoring and reviewing critical manufacturing and validation documentation, including Process Performance Qualification (PPQ) protocols and reports. Additional responsibilities include performing data verification activities to ensure accuracy and traceability of source data, supporting regulatory filing documentation, and developing Master Sample Matrices (MSM) used by manufacturing personnel during production floor operations.
Required Skills:
  • Bachelor's degree in Life Sciences, Pharmaceutical Sciences, Biotechnology, Biochemistry, Chemistry, Chemical Engineering, or a related scientific discipline.
  • Minimum 5 years of experience within pharmaceutical, biotechnology, biologics, sterile manufacturing, or regulated life sciences environments.
  • Direct experience authoring and/or reviewing GMP manufacturing documentation such as Process Performance Qualification (PPQ) protocols and reports, technical reports, validation documentation, investigation reports, process transfer documentation, manufacturing support documents, or regulatory submission content.
  • Demonstrated understanding of parenteral drug product manufacturing operations, including aseptic filling, filling isolators, lyophilization, visual inspection, packaging, and associated manufacturing processes.
  • Experience supporting commercial or clinical manufacturing operations within a cGMP-regulated pharmaceutical or biotechnology environment.
  • Ability to interpret manufacturing data, process parameters, batch records, validation results, and technical datasets and translate findings into clear, compliant technical documentation.
  • Working knowledge of Process Performance Qualification (PPQ), Continued Process Verification (CPV), process validation, deviation investigations, change controls, and regulatory expectations associated with pharmaceutical manufacturing.
  • Familiarity with FDA, EMA, ICH, and cGMP regulations governing pharmaceutical manufacturing, validation, and documentation practices.
  • Strong scientific writing skills with experience preparing documentation subject to Quality Assurance review and regulatory inspection.
  • Proven ability to collaborate with Manufacturing Sciences, Technical Operations, Process Development, Validation, Quality Assurance, Regulatory Affairs, and Manufacturing teams in support of clinical and commercial drug product manufacturing.
Preferred Qualifications
  • Experience supporting sterile injectable, biologic, vaccine, or parenteral drug product manufacturing facilities.
  • Previous experience authoring PPQ protocols and reports for regulatory submissions or commercial manufacturing programs.
  • Experience supporting technology transfer, process characterization, process validation, or regulatory filing activities.
  • Advanced degree (M.S. or Ph.D.) in Pharmaceutical Sciences, Biotechnology, Chemistry, Chemical Engineering, or a related scientific field.
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About the Company

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The Fountain Group LLC

The Fountain Group provides Contingent Labor, Statement-of-Work, and Contingent-to-Permanent resources to clients with an internal/external Contingent Labor Managed Service Program or Clients without a program. The Fountain Group is committed to the belief that we all share in the responsibility to conduct our businesses in a socially and environmentally responsible manner. We base this on the premise that a company is much more than the products it offers. The effect a company has on the environment, the people and the communities it serves reflects the company’s dedication to being not only a good business, but to being a good corporate citizen. The Fountain Group believes the key to servicing a client is to identify the client demand precisely. Therefore, The Fountain Group focused its efforts on building and developing a process, which can identify an exact match for our client’s needs. Our process utilizes modern technology combined with 30+ years of Talent Acquisition experience to deliver Precision resources. Financial strength is prominent among The Fountain Group’s corporate values. The future of our business will be built on the innovation, compassion, outstanding services and technology, but a solid financial foundation is required to carry us forward to meet our business goal and support our long term vision.

COMPANY SIZE
500 to 999 employees
INDUSTRY
Staffing/Employment Agencies
WEBSITE
https://www.thefountaingroup.com/

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