This is a remote position.
PSC Software a division of PSC Biotech is a leading provider of cutting-edge cloud-based quality management and regulatory compliance solutions. Our software helps organizations streamline processes ensure compliance and improves overall efficiency delivering exceptional value to our clients. With specialization in meeting the needs of pharmaceutical medical device and other highly regulated industries.
At PSC Software we are passionate about providing innovative software solutions that empower businesses to achieve their full potential.
The Experience
With operations spanning the globe and featuring a multicultural team PSC Biotech is passionate about bringing the best and brightest together 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 a compensation and benefits structure that rewards you but also be provided with the tools that will help you grow and learn.
At PSC Biotech its about more than just a jobits about your career and your future.
Your Role
We are hiring a Technical Writer to support our Software Team. The Technical Writer will translate business specifications into user documentation and is responsible for planning writing and maintaining systems and user support documentation efforts including online help screen. This position is familiar with a variety of the fields concepts practices and procedures. A wide degree of creativity and latitude is expected. This is a remote position that must work within U.S Timezone working hours.
- Create and maintain technical documents for all PSC Software applications that are developed in-house. These documents include user administration API and quick start manuals for ACE and Audit Utopia applications.
- Support required detail-oriented configuration of the PSC Software proprietary enterprise software.
- Configure proof of concept demonstrations to adapt ACE to necessary needs.
- Support software requirements analysis customizations enhancements integrations and production deployments of customers/partners.
- Works closely and collaboratively with project managers product managers operations and other engineers to ensure high-quality implementation on-time delivery and post-implementation technical support.
- Interface with internal stakeholders for technical support/sustainment.
- Write technical documents including requirements product customizations and integration capabilities.
- Comply maintain and improve the internal quality systems.
- Participate in ongoing technical support training and service.
- Learn to perform critical software documentation with an eye for detail and rigid application of best practices and procedures.
- Other duties as assigned.
Requirements
- Bachelors Degree in related STEM fields or equivalent.
- At least 2 years of Technical Writing experience related to software specifications and products.
- Experience with Technical Writing for cGxP systems or facilities preferably pharmaceuticals.
- Knowledge of FDA Regulations.
- Knowledge and experience with Clinical and Regulatory Affairs documentation in a regulated environment.
- Excellent verbal and written communication skills.
- Strong organizational skills.
- Excellent analytical skills.
- Ability to work independently in a remote setting.
- Must be able to work within U.S Timezone working hours.
Benefits
Equal Opportunity Employment Statement
BioTechnique 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 applicants employees or interns 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-DC1
Required Skills:
Bachelors degree in Engineering Life Sciences or a related field. Proven experience in equipment commissioning qualification and validation engineering experience in the pharmaceutical manufacturing industry. Strong knowledge of regulatory requirements and industry understanding of risk-based validation and full life cycle approach. Experience qualifying large process equipment and supporting utilities (i.e. vessels CIP/SIP skids isolators autoclaves WFI clean steam etc.) Cell and gene therapy experience preferred. Experienced with paperless validation systems i.e. Kneat Excellent analytical and technical problem solving skills. Strong technical writing skills and understanding of full lifecycle documentation (protocols reports procedures risk assessments specifications and requirements etc.) Effective communication and interpersonal skills. Proactive with strong organization time management and project management abilities. Excellent attention to detail with commitment to quality and compliance. At PSC Biotech many of our projects and clients are located in various regions around the country. Therefore we value candidates who are willing and able to travel as needed for project assignments and client engagements. The ability to adapt to different locations cultures and work environments is essential as it allows our team members to collaborate effectively with clients and colleagues nationally. Must be authorized to work in the US. No C2C at this time
This is a remote position. PSC Software a division of PSC Biotech is a leading provider of cutting-edge cloud-based quality management and regulatory compliance solutions. Our software helps organizations streamline processes ensure compliance and improves overall efficiency delivering except...
This is a remote position.
PSC Software a division of PSC Biotech is a leading provider of cutting-edge cloud-based quality management and regulatory compliance solutions. Our software helps organizations streamline processes ensure compliance and improves overall efficiency delivering exceptional value to our clients. With specialization in meeting the needs of pharmaceutical medical device and other highly regulated industries.
At PSC Software we are passionate about providing innovative software solutions that empower businesses to achieve their full potential.
The Experience
With operations spanning the globe and featuring a multicultural team PSC Biotech is passionate about bringing the best and brightest together 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 a compensation and benefits structure that rewards you but also be provided with the tools that will help you grow and learn.
At PSC Biotech its about more than just a jobits about your career and your future.
Your Role
We are hiring a Technical Writer to support our Software Team. The Technical Writer will translate business specifications into user documentation and is responsible for planning writing and maintaining systems and user support documentation efforts including online help screen. This position is familiar with a variety of the fields concepts practices and procedures. A wide degree of creativity and latitude is expected. This is a remote position that must work within U.S Timezone working hours.
- Create and maintain technical documents for all PSC Software applications that are developed in-house. These documents include user administration API and quick start manuals for ACE and Audit Utopia applications.
- Support required detail-oriented configuration of the PSC Software proprietary enterprise software.
- Configure proof of concept demonstrations to adapt ACE to necessary needs.
- Support software requirements analysis customizations enhancements integrations and production deployments of customers/partners.
- Works closely and collaboratively with project managers product managers operations and other engineers to ensure high-quality implementation on-time delivery and post-implementation technical support.
- Interface with internal stakeholders for technical support/sustainment.
- Write technical documents including requirements product customizations and integration capabilities.
- Comply maintain and improve the internal quality systems.
- Participate in ongoing technical support training and service.
- Learn to perform critical software documentation with an eye for detail and rigid application of best practices and procedures.
- Other duties as assigned.
Requirements
- Bachelors Degree in related STEM fields or equivalent.
- At least 2 years of Technical Writing experience related to software specifications and products.
- Experience with Technical Writing for cGxP systems or facilities preferably pharmaceuticals.
- Knowledge of FDA Regulations.
- Knowledge and experience with Clinical and Regulatory Affairs documentation in a regulated environment.
- Excellent verbal and written communication skills.
- Strong organizational skills.
- Excellent analytical skills.
- Ability to work independently in a remote setting.
- Must be able to work within U.S Timezone working hours.
Benefits
Equal Opportunity Employment Statement
BioTechnique 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 applicants employees or interns 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-DC1
Required Skills:
Bachelors degree in Engineering Life Sciences or a related field. Proven experience in equipment commissioning qualification and validation engineering experience in the pharmaceutical manufacturing industry. Strong knowledge of regulatory requirements and industry understanding of risk-based validation and full life cycle approach. Experience qualifying large process equipment and supporting utilities (i.e. vessels CIP/SIP skids isolators autoclaves WFI clean steam etc.) Cell and gene therapy experience preferred. Experienced with paperless validation systems i.e. Kneat Excellent analytical and technical problem solving skills. Strong technical writing skills and understanding of full lifecycle documentation (protocols reports procedures risk assessments specifications and requirements etc.) Effective communication and interpersonal skills. Proactive with strong organization time management and project management abilities. Excellent attention to detail with commitment to quality and compliance. At PSC Biotech many of our projects and clients are located in various regions around the country. Therefore we value candidates who are willing and able to travel as needed for project assignments and client engagements. The ability to adapt to different locations cultures and work environments is essential as it allows our team members to collaborate effectively with clients and colleagues nationally. Must be authorized to work in the US. No C2C at this time
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Posted on:
18 hours ago
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