CQV Technical Writer

PSC Biotech provides the life sciences with essential services to ensure that health care products are developed manufactured and distributed to the highest standards in compliance with all applicable regulatory requirements.

Our goal is to skyrocket our clients success and you can be a part of our team s achievements. Employing a global team of skilled professionals and experts that span across strategically located offices in North America Europe Asia and the Middle East we are proud of the roles we have fulfilled to help our clients achieve success.

The Experience

With operations spanning the globe and featuring a multicultural team PSC Biotech is passionate about bringing the best and brightest together in an effort to form something truly special. When you make the decision to join our team you will be offered the ability to feel inspired in your career explore your professional passions and work alongside a group of people who will value and nurture your talents.

We are firm believers in coaching and developing the next generation of industry leaders and influencers. As such you will not only be offered compensation and benefits structure that rewards you but also be provided with the tools that will help you grow and learn.

At PSC Biotech it s about more than just a job it s about your career and your future.

Your Role

We are hiring a Technical Writer to support large Commissioning Qualification and Validation (CQV) projects within the pharmaceutical manufacturing industry. The Technical Writer will be responsible for developing and maintaining documentation ensuring compliance with industry standards and regulations.

• Develop write review edit and approve commissioning qualification and validation documentation including IQ OQ PQ protocols reports and standard operating procedures (SOPs).
  
• Collaborate with crossfunctional teams to gather technical information and ensure accurate representation in documentation.
  
• Ensure all documentation complies with industry standards regulations and company policies.
  
• Regularly review and update existing documentation to reflect changes in processes equipment or regulatory requirements.
  
• Identify and support process improvement efforts (root cause analysis/investigations/corrective actions/etc.).
  
• Communicate and collaborate with team members and project staff to plan develop and produce highquality communication products in a fastpaced environment.
  
• Demonstrate excellent technical problemsolving skills to address complex validation challenges.
  
• Additional responsibilities as required.
  

Requirements

• Bachelors degree in a relevant scientific or engineering field.
  
• 35years of experience supporting commissioning qualification and validation engineering projects and technical documentation.
  
• Proven ability to write clear concise and accurate technical documentation.
  
• Solid understanding of engineering principles terminology processes and concepts.
  
• Strong understanding of industry regulations and standards.
  
• Excellent written and verbal communication skills.
  
• Ability to work independently and collaboratively in a remote team environment.
  
• Detailoriented with a focus on accuracy and consistency.
  
• Strong organizational skills with the ability to multitask and manage multiple documentation projects.
  
• Knowledge of riskbased validation principles.
  
• Familiarity with document management systems and electronic document control.
  

Equal Opportunity Employment Statement:

PSC is committed to 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 employersponsored 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.

#LIFF1

Bachelor's degree in a relevant scientific or engineering field. 3-5+years of experience supporting commissioning, qualification, and validation engineering projects and technical documentation. Proven ability to write clear, concise, and accurate technical documentation. Solid understanding of engineering principles, terminology, processes, and concepts. Strong understanding of industry regulations and standards. Excellent written and verbal communication skills. Ability to work independently and collaboratively in a remote team environment. Detail-oriented with a focus on accuracy and consistency. Strong organizational skills with the ability to multi-task and manage multiple documentation projects. Knowledge of risk-based validation principles. Familiarity with document management systems and electronic document control. Equal Opportunity Employment Statement: PSC is committed to 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. #LI-FF1