PharmEng Nordic ApS
About the job Pharmaceutical Technical Writer
Technical Writer Engineering & Utilities (Pharma)
Location:
Albany, NY (Hybrid One Week Onsite Per Month) Duration:
Long-Term Contract We are seeking a
Technical Writer
with experience in
engineering documentation
for a
pharmaceutical manufacturing environment , with a strong focus on
utilities and facility systems . The ideal candidate will have expertise in developing, reviewing, and managing technical documents while ensuring compliance with
GMP and regulatory standards . This
hybrid role requires one week onsite per month
to collaborate with stakeholders and gather critical technical information. Key Responsibilities:
Documentation Development:
Create, update, and maintain SOPs, technical manuals, work instructions, and engineering documentation related to
utilities (HVAC, WFI, compressed air, purified water, clean steam, etc.) Collaboration & Content Gathering:
Work closely with
engineering, facilities, validation, and quality teams
to collect and document technical requirements Regulatory Compliance:
Ensure all documentation meets
FDA, cGMP, and industry standards Document Workflow Management:
Utilize electronic document management systems (EDMS) such as
Veeva Vault, MasterControl, Documentum, or OpenText
to manage approval workflows Process Improvement:
Assist in standardizing documentation processes, version control, and ensuring consistency across engineering records Technical Editing & Formatting:
Review technical content for clarity, accuracy, and compliance with company style guides Qualifications & Experience:
Experience:
3+ years as a
Technical Writer
in a
pharmaceutical, biotech, or regulated manufacturing
setting Technical Knowledge:
Experience documenting
engineering processes, utilities, and facility systems Software & Workflow Management:
Proficiency in
EDMS platforms
such as
Veeva Vault, MasterControl, Documentum, OpenText, or similar Regulatory & Compliance:
Familiarity with
GMP, FDA 21 CFR Part 11, and industry best practices Skills:
Strong attention to detail, ability to interpret technical concepts, excellent communication, and organizational skills This is a
long-term hybrid opportunity
to work in a cutting-edge
pharmaceutical manufacturing environment , contributing to critical engineering and utility documentation. Interested? Apply now or DM for details!
#J-18808-Ljbffr
Technical Writer Engineering & Utilities (Pharma)
Location:
Albany, NY (Hybrid One Week Onsite Per Month) Duration:
Long-Term Contract We are seeking a
Technical Writer
with experience in
engineering documentation
for a
pharmaceutical manufacturing environment , with a strong focus on
utilities and facility systems . The ideal candidate will have expertise in developing, reviewing, and managing technical documents while ensuring compliance with
GMP and regulatory standards . This
hybrid role requires one week onsite per month
to collaborate with stakeholders and gather critical technical information. Key Responsibilities:
Documentation Development:
Create, update, and maintain SOPs, technical manuals, work instructions, and engineering documentation related to
utilities (HVAC, WFI, compressed air, purified water, clean steam, etc.) Collaboration & Content Gathering:
Work closely with
engineering, facilities, validation, and quality teams
to collect and document technical requirements Regulatory Compliance:
Ensure all documentation meets
FDA, cGMP, and industry standards Document Workflow Management:
Utilize electronic document management systems (EDMS) such as
Veeva Vault, MasterControl, Documentum, or OpenText
to manage approval workflows Process Improvement:
Assist in standardizing documentation processes, version control, and ensuring consistency across engineering records Technical Editing & Formatting:
Review technical content for clarity, accuracy, and compliance with company style guides Qualifications & Experience:
Experience:
3+ years as a
Technical Writer
in a
pharmaceutical, biotech, or regulated manufacturing
setting Technical Knowledge:
Experience documenting
engineering processes, utilities, and facility systems Software & Workflow Management:
Proficiency in
EDMS platforms
such as
Veeva Vault, MasterControl, Documentum, OpenText, or similar Regulatory & Compliance:
Familiarity with
GMP, FDA 21 CFR Part 11, and industry best practices Skills:
Strong attention to detail, ability to interpret technical concepts, excellent communication, and organizational skills This is a
long-term hybrid opportunity
to work in a cutting-edge
pharmaceutical manufacturing environment , contributing to critical engineering and utility documentation. Interested? Apply now or DM for details!
#J-18808-Ljbffr