Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.
We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:
- Document Control Specialist
Description:
- Manage controlled documents (SOPs, batch records, protocols, forms) and maintain version control.
- Work with multiple departments to ensure accuracy and quality of document change processes.
- Work with SME's to prepare, update, and review for submission of controlled documents.
Qualifications:
- Bachelor's degree in Science, Pharmacy, Biology, Chemistry, or Business/Administration.
- Minimum 3 years' experience in document control within the pharmaceutical, biotech, or regulated manufacturing environment.
- Strong written and verbal communication skills in both Spanish and English (bilingual).
- Proven experience managing controlled documents (SOPs, batch records, protocols, forms) and maintaining version control.
- Familiar with regulatory requirements (cGMP, FDA, EMA) and compliant document lifecycle practices.
- Skilled in document management systems (DMS) and Microsoft Office (Word, Excel, PowerPoint); experience with enterprise QMS tools preferred.
- Ability to review and improve document formats and structure for clarity, compliance, and usability.
- Coordinate and track training on SOPs and document-related procedures; ensure field resources are trained and records are maintained.
- Detail-oriented, excellent proofreading/editing skills, and capable of producing clear, professional documentation.
- Flexible schedule; willing to work occasional additional hours and rarely on Saturdays when required to meet project deadlines or support critical activities.
At Validation & Engineering Group, people always come first. We believe that when you're empowered to do your best work, bold ideas thrive and real progress happens. This isn't just a job - it's an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose-driven, supportive team.
Excited to build something meaningful together? We look forward to hearing from you.
Validation & Engineering Group is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.
Skills Required
- Bachelor's degree in Science, Pharmacy, Biology, Chemistry, or Business Administration
- At least 3 years of document control experience in a pharmaceutical, biotechnology, or regulated manufacturing environment
- Strong written and verbal communication skills in Spanish and English
- Experience managing controlled documents, including SOPs, batch records, protocols, and forms
- Experience maintaining document version control
- Familiarity with cGMP, FDA, EMA, and compliant document lifecycle practices
- Proficiency with document management systems and Microsoft Office, including Word, Excel, and PowerPoint
- Experience with enterprise QMS tools
- Ability to review and improve document formats and structure for clarity, compliance, and usability
- Ability to coordinate and track SOP and document-procedure training and maintain training records
- Excellent proofreading and editing skills
- Ability to work a flexible schedule, including occasional additional hours and rare Saturdays
What We Do
Pinnaql, Inc. is a professional services consulting firm providing quality, regulatory, and operational excellence solutions to biopharmaceutical, medical device, and CDMO companies worldwide. The company specializes in laboratory validation, engineering, and compliance, helping regulated life sciences organizations navigate manufacturing challenges, reduce execution risks, and accelerate the transition from lab innovation to commercial market readiness.
