[Hiring] Validation and Operations Specialist @PSC Biotech

Role Description

We’re seeking a versatile professional who thrives at the intersection of validation, technical writing, project coordination, and executive support. You’ll own documentation and validation deliverables, keep cross‑functional projects on track, and provide high‑impact support to senior leadership. This is a fully remote position with collaboration across U.S time zones.

• Develop, author, and maintain validation documentation (e.g., URS/FDS, IQ/OQ/PQ protocols, test plans, risk assessments, reports).
• Partner with SMEs to ensure documentation meets regulatory, compliance, and internal quality standards.
• Track validation activities, deviations, CAPA items, and change controls; maintain auditable records and version control.
• Write and edit SOPs, work instructions, technical guides, and partner/client‑facing documentation.
• Translate complex technical concepts into clear, accurate content tailored to audiences (engineering, QA/RA, business stakeholders).
• Perform audits for clients when needed. Both Gap assessments and supplier audits.
• Establish templates, style guides, and document workflows to improve consistency and speed.
• Manage calendars, briefing materials, travel logistics, and confidential communications for one or more executives.
• Prepare meeting packets, decision memos, and executive dashboards; anticipate needs and unblock decision‑making.
• Gate keep and prioritize inbound requests; streamline workflows and information flow.
• Assist with light content development (blog posts, one‑pagers, slide decks), brand‑aligned edits, and case‑study packaging.
• Help coordinate campaigns, events/webinars, and CRM updates; track basic performance metrics.

Qualifications

• 3–7 years of blended experience across validation/quality, technical writing, project coordination, and executive assistant duties.
• Some travel up to 25% of the time to accomplish client projects or development work.
• Demonstrated proficiency in writing technical protocols, SOPs, and/or regulated documentation; strong attention to detail and version control.
• Solid project coordination skills: scheduling, RAID logs, stakeholder updates, and meeting facilitation.
• Executive support experience: calendar and travel management, briefing prep, discretion with sensitive information.
• Excellent written and verbal communication; ability to tailor messages to technical and non‑technical audiences.
• Comfort with productivity/PM tools (e.g., Microsoft 365, SharePoint, Teams, OneDrive, Planner, or equivalents); basic familiarity with CRM or marketing tools is a plus.
• Marketing exposure (content edits, collateral, basic analytics) preferred—willing to train if other capabilities are exceptional.
• Self‑starter, organized, and resourceful; thrives in a remote, fast‑paced environment.
• Must be able to work during standard U.S time zone hours.

Benefits

• Equal Opportunity Employment Statement
• PSC Biotech is committed to a policy of Equal Employment Opportunity with respect to all employees, interns, and applicants for employment.
• Consistent with this commitment, our policy is to comply with all applicable federal, state and local laws concerning employment discrimination.
• Accordingly, the Company prohibits discrimination against qualified employees, interns and applicants in all aspects of employment including, but not limited to: recruitment, interviewing, hiring (or failure or refusal to hire), evaluation, compensation, promotion, job assignment, transfer, demotion, training, leaves of absence, layoff, benefits, use of facilities, working conditions, termination and employer-sponsored activities and programs, including wellness, social and recreational programs.
• Employment decisions will be made without regard to an applicant’s, employee’s, or intern’s actual or perceived: race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age (40 or older), disability, genetic information, or any other status protected by law.