Technical Writer
PSCBiotech provides the life sciences with essential services toensure that health care products are developed manufactured anddistributed to the highest standards in compliance with allapplicable regulatory requirements.
Ourgoal is to skyrocket our clients success and you can be a part ofour team s achievements. Employing a global team of skilledprofessionals and experts that span across strategically locatedoffices in North America Europe Asia and the Middle East we areproud of the roles we have fulfilled to help our clients achievesuccess.
TheExperience
Withoperations spanning the globe and featuring a multicultural teamPSC Biotech is passionate about bringing the best and brightesttogether in an effort to form something truly special.
When youmake the decision to join our team you will be offered the abilityto feel inspired in your career explore your professional passionsand work alongside a group of people who will value and nurtureyourtalents.
Weare firm believers in coaching and developing the next generationof industry leaders and influencers. As such you will not only beoffered compensation and benefits structure that rewards you butalso be provided with the tools that will help you grow andlearn.
AtPSC Biotech it s about more than just a job it s about your careerand yourfuture.
YourRole
Weare hiring an experienced Technical Writer and Validation Engineer.This position will play a critical role in supporting multipleprojects through technical writing commissioning qualification andvalidation activities.
Successful candidates are able to hit theground running possess effective communication skills and a strongtechnical background.
- Collaboratewith crossfunctional teams to gather / align information and gainthorough understanding of technical requirements.
- Writedevelop review and approve technical documentation including butnot limited to CQV protocols user requirement specificationsfunctional specifications equipment specification documentationprocedures summary reports and so on.
- Proactivelyensure accuracy and completeness of all required technicaldocumentation.
- Managedocumentation updates and revisions.
- Executerequired commissioning qualification and validation protocols for arange of specialty and process equipment.
- Conductsite and factory acceptance testing.
- Additionalresponsibilities as required.
Requirements
- Bachelorsdegree in related engineering discipline.
- 5years of experience in a technical writing role and experiencedexecuting CQV activities.
- Experiencedwith process equipment including but not limited to CTUsbioreactors lyophilizers chrome skids etc.
- Expereriencein the peptide manufacturing space is a plus.
- Automationengineering background is a plus.
- Experiencedwith a range of technical writing software and systems.
- Knowledgeof master controls.
- Excellenttechnical writing skills with strong attention to detail andcommitment to quality and compliance.
- Strongunderstanding of regulatoryrequirements.
- Excellentcommunication and interpersonal skills.
- Abilityto hit the ground running and work both independently andcollaboratively in a fastpaced environment with changing prioritiesanddeadlines.
- Strongorganizational and timemanagement skills with the ability toprioritize tasks and manage multiple projectssimultaneously.
- AtPSC Biotech many of our projects and clients are located in variousregions around the country. Therefore we value candidates who arewilling and able to travel as needed for project assignments andclient engagements.
The ability to adapt to different locationscultures and work environments is essential as it allows our teammembers to collaborate effectively with clients and colleaguesnationally.
Benefits
Offeringa full suite of benefits PSC Biotech is firmly focused ondiligently investing in our employees who enable our company tofulfill our mission and achieve success.
We want to promote balanceso you not only enjoy your work but also have the time andresources to live your life happy and healthy.
MedicalDental and Vision PSC pays 100% of all qualifying employee medicalpremiums and 50% for qualifyingdependents
Insuranceoptions for Employee Assistance Programs Basic Life InsuranceShort / Long Term Disability andmore.
401(k)and 401(k)matching
PTOSick Time and PaidHolidays
EducationAssistance
PetInsurance
Discountedrate at AnytimeFitness
FinancialPerks andDiscounts
Estimatedannual salary (dependent on experience) $100000$118000
EqualOpportunity EmploymentStatement :
PSCis committed to is committed to a policy of Equal EmploymentOpportunity with respect to all employees interns and applicantsfor employment.
Consistent with this commitment our policy is tocomply with all applicable federal state and local laws concerningemployment discrimination.
Accordingly the Company prohibitsdiscrimination against qualified employees interns and applicantsin all aspects of employment including but not limited to : recruitment interviewing hiring (or failure or refusal to hire)evaluation compensation promotion job assignment transfer demotiontraining leaves of absence layoff benefits use of facilitiesworking conditions termination and employersponsored activities andprograms including wellness social and recreational programs.
Employment decisions will be made without regard to an applicant semployee 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 orany other status protected bylaw.
LIAS1
Bachelor's degree in related engineering discipline. 5+ years ofexperience in a technical writing role and experienced executingCQV activities.
Experienced with process equipment, including butnot limited to CTUs, bioreactors, lyophilizers, chrome skids, etc.Expererience in the peptide manufacturing space is a plus.
Automation engineering background is a plus. Experienced with arange of technical writing software and systems. Knowledge ofmaster controls.
Excellent technical writing skills, with strongattention to detail and commitment to quality and compliance.Strong understanding of regulatory requirements.
Excellentcommunication and interpersonal skills. Ability to hit the groundrunning and work both independently and collaboratively in afast-paced environment with changing priorities and deadlines.
Strong organizational and time-management skills, with the abilityto prioritize tasks and manage multiple projects simultaneously.
AtPSC Biotech, many of our projects and clients are located invarious regions around the country. Therefore, we value candidateswho are willing and able to travel as needed for projectassignments and client engagements.
The ability to adapt todifferent locations, cultures, and work environments is essential,as it allows our team members to collaborate effectively withclients and colleagues nationally.