Validation Analyst

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.

We are PCI.

Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.

JOB SUMMARY

• Performs validation activities to assure compliance to government and customer requirements.

• Ensures validation documentation completion, accuracy, and closure, including organizing and coordinating multiple approvals as required

• Effectively communicates project goals and progress to Validation Supervisor/Manager

• Reviews and interprets standards, procedures and specifications for dissemination relative to validation protocols.

• Knowledge of and adherence to all PCI, cGMP, GCP, GAMP, 21CFR, 21CFR Part 11 and Annex 11 policies, procedures, rules, and requirements.

• This position may require overtime and/or weekend work.

• Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules.

• Attendance to work is an essential function of this position

• May perform technical writing in developing protocols and writing reports

• Execution of validation protocols

• Perform Environmental Monitoring in operational and sampling areas

• Performs other duties as assigned by Manager/Supervisor

Required:

• Bachelor's Degree in a related field and/or 1 -5 years related experience and/or training.

• Basic Mathematical Skills

• Basic Computer Skills: Ability to perform basic computer tasks and has the ability to operate common computer programs.

• Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels

pertinent to professional needs.

• High Reasoning: Ability to solve practical problems and deal with a variety of concrete variables in

situations where there is only limited standardization.

• Ability to interpret a variety of instructions that may be provided in various forms.

Preferred:

• Ability to effectively present information to various people as the job requires.

• Ability to work independently and/or part of a team.

• Ability to demonstrate attention to detail.

• Ability to follow instructions and respond to management direction.

Join us and be part of building the bridge between life changing therapies and patients. Let's talk future (~~~/)

Equal Employment Opportunity (EEO) Statement:

PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

Why work for PCI Pharma Services?

At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don't say no, we figure out how.

PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled