Validation Analyst 1 - Mississauga, Canada - PCI Pharma Services

PCI Pharma Services

Verified Company

Mississauga, Canada

1 week ago

Posted by:

Sophia Lee

beBee Recruiter

Description

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.

Summary

Responsible for planning, executing and leading various validation project assignments.

Including execution of line trials, development of validation strategy, qualification of equipment, processes, instrumentation and systems related to the packaging operation.

Works closely with Tech Services, Production and Customer Service teams to ensure customer specifications are met and that these specifications comply with internal operating standards.

Provides oversight on validation projects and reports status of projects to the Quality Director.

Essential Duties and Responsibilities:

Qualifications:
The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Required:

BSc in engineering or related scientific field, Mechanical engineering preferred.
Minimum 5 years' experience with pharmaceutical manufacturing and/or packaging.
Indepth knowledge of GMP's, with 3 years' experience in a Validation / Engineering role.
Exceptional attention to detail and accuracy in the maintenance of records and data.
Exceptional attention to detail and accuracy in the maintenance of records and data.
Effective interpersonal and teamwork skills.
Able to problem solve, coach as well as influence and negotiate at all levels within the organization.
Extensive computer knowledge and adeptness with various software programs including Microsoft Office and database management.
Excellent English language written and oral communication skills.
Able to oversee multiple project assignments, direct daily activities and provide on the job training to employees.

Preferred:

Process/

Cleaning Validation Focus:
Background in Packaging, Pharmaceutical, Bio-Pharmaceutical, and/or Medical Devices. Must be able to properly gown and work in an active packaging operation.

HVAC/

Utility Validation Focus:

Familiarity with HVAC wiring diagrams, control design, calibration, instrument configuration, and fundamentals of heating, air conditioning, and refrigeration systems.

Computer Validation Focus: Associate's Degree in a related field and/or 13 years related experience and/or training. Ability to perform complex computer tasks and have some experience with computer systems considered to have an impact on cGMP, cGXP, Annex 11 and PCI guidelines.

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._