Senior QA Validation Specialist CSV Systems Engineer

Job description

Senior QA Validation Specialist - CSV Systems Engineer

Summary:

The Senior Validation Specialist, assists with the validation activities throughout the plant, coordinates appropriate support and assists in completing validation activities and provides technical assistance to Engineering Services, R&D, Production, Maintenance and QA/QC in Validation and Quality Assurance-related issues.

This role serves as a source of expertise in the group for validating new systems and processes.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.

The requirements listed below are representative of the knowledge, skill, and/or ability required.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Join our talented workforce, where a commitment to excellence and a customer focused attitude is everything.

We pursue excellence because our work has the power to improve patients’ lives with the pharmaceuticals we develop and manufacture.



We proudly offer


+ Generous benefit options

+ Paid training, vacation and holidays

+ Career advancement opportunities

+ Education reimbursement

+ 401k program

+ And more!


Supervisory responsibilities

This position does not have supervisory responsibilities.

Essential job duties


+ Provide quality review and approval of validation activities associated with changes to existing systems and projects that support the site

+ Support protocol development and approval, investigations for deviations and champion local, corporate and regulatory standards

+ Present and support validation concepts and approaches with audits and inspections

+ Provide Quality validation review and approval through the preparation, execution, data analysis, and report writing for IQ, OQ and PQ protocols

+ Quality review and approval of Change Requests (CR’s) related to project validation and other validation activities for the site

+ Perform compliance and technical reviews/approvals of protocols and protocol data

+ Review and approve validation failure investigations and non-conformities utilizing root cause analysis techniques

+ Review and approve specifications, procedures, and other required supporting documents to maintain the validated state of equipment and processes and the validation

+ Identify process improvements before equipment, systems or processes are placed under change control during validation

+ Manage and complete each assigned Annual Product Review (APR).

This includes cooperating transversally with various departments and to ensure that data is supplied on time and is sufficient and compliant with appropriate procedures

+ Communicate validation issues and requirements to plant personnel on a frequent basis through participation in Engineering, R&D and management staff meetings, as well as applicable project teams

+ Track all validation documentation throughout the plant and follow-up as needed

+ Exhibit safety awareness and safe work practices


Education, experience, certification and licensures Required

·BA/BS Degree in Chemistry, Engineering or a relevant field and 8 years of related work experience in validation/quality related discipline or drug development

OR

·MA/MS Degree in Chemistry, Engineering or a relevant field and 6 years of related work experience in validation/quality related discipline or drug development

OR

·PhD in Chemistry, Engineering or a relevant field and 4 years of related work experience in validation/quality related discipline or drug development

Preferred

· Leadership experience

Knowledge, skills and abilities


+ Expert in quality concepts including technical and compliance review of documents

+ Expert competence in one or more core validation areas (Equipment qualification, packaging, cleaning, utilities, process or computer validation)

+ Expert in cGMP documentation practices


Physical requirements

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to sit; use hands to finger, handle, or feel; and talk or hear.

The employee is occasionally required to stand, walk, and reach with hands and arms.

The employee must frequently lift and/or move up to 10 pounds.

Specific vision abilities required by this job include close vision, and ability to adjust focus.

Work environment

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee has the potential of being exposed to fumes or airborne particles and toxic or caustic chemicals (wearing proper Personal Protective Equipment will be required in these situations).

The employee is occasionally exposed to wet and/or humid conditions; moving mechanical parts; high, precarious places; outside weather conditions; and may be expected to work with electronic equipment (always being aware of one’s environment and taking proper precautions is required).

The noise level in the work environment is usually moderate.

Employee may be responsible for moving and/or generating hazardous waste for treatment, storage and disposal.

Affected employee will need to be familiar with the applicable training requirements included in the customized Resources, Conservation and Recovery Act.

Employee will understand waste labeling, secondary containment, chemical compatibility, storage time limits, container size and quantity limits, container integrity when waste is left unattended and improper disposal of hazardous materials.

The above statements are intended to describe the general nature and level of work performed by people assigned to this classification.

They are not intended to be construed as an exhaustive list of all job duties performed by the personnel as classified.

Management reserves the right to revise or amend duties at any time.

Pay Range: $90,000 – 112,400

Education, experience, location and tenure may be considered along with internal equity when job offers are extended.

We do not accept unsolicited assistance from any headhunters or recruitment firms for any of our job openings.

All resumes or profiles submitted by search firms to any employee at Curia, in any form without a valid, signed search agreement by an authorized signatory in place for the specific position, approved by Talent Acquisition, will be deemed the sole property of Curia.

No fee will be paid in the event the candidate is hired by Curia because of the unsolicited referral.

All interested applicants must apply online.

Please be aware of scammers.

Curia will only send offer letters and requests for sensitive personal information from a curiaglobal.com email address.

Curia is an Equal Opportunity Employer.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Curia is an E-Verify employer.

#LI-DR1

Required Skill Profession

Other General