Associate Specialist, Validation

BiovireBrighton, MI, US

20 days ago

Job type

Full-time

Job description

Job Description

General Description

The Associate Specialist, Validation will support Biovire by performing facility, utility and equipment qualification activities as per company test protocols to ensure that these systems meet all requirements to support the manufacture of commercial pharmaceutical products. This role provides tremendous Engineering & Quality experience for anyone who wants to build a career in pharmaceutical manufacturing.

DUTIES AND RESPONSIBILITIES

Support implementation of facility modifications, new utilities and new equipment by executing test protocols to ensure the systems are installed, operational and performing correctly.

This includes safety testing, utility requirements, functionality testing, determination of operating ranges of critical process parameters, user access & control, establishing Preventative Maintenance plans, spare parts lists, calibrations, alarm response, etc.

Author risk assessments to determine how much qualification testing is required on new systems.

Summarize the capabilities of GMP systems controlled by a computer, to ensure that any system that generates data meets regulatory requirements.

Perform periodic assessments of GMP systems to ensure that previous validation activities are updated to capture new regulatory requirements.

Collaborate with the end user departments to ensure user requirements are captured prior to executing test protocols.

Must be someone with a "can do" attitude, eager to make a difference.

Strong understanding & comprehension of English is required, as most work activities require significant documentation that must meet stringent regulatory requirements.'

Must be willing to work "hands on" with equipment.

Physical requirements include ladder use (ie, heights), lifting up to 20 pounds unassisted.

Must be willing & able to wear appropriate PPE.

Behavioral Expectations :

Strong work ethic and ability to accomplish tasks without supervision.

Excellent interpersonal skills with the ability to cooperate with others in a high-performance setting.

Strong mathematical and organizational skills.

English communication skills, both written and verbal.

Must possess honesty and integrity, commitment to the highest legal and ethical standards

Ability to treat every person with courtesy and respect

Demonstrate ownership and accountability to production schedule without compromising product quality

Desire to work with others and share best practices with colleagues on their shift and on other shifts

Knowledge of fundamental cGMP and regulatory principles

WORK EXPERIENCE AND EDUCATION REQUIREMENTS

A Bachelor of Science in Engineering or equivalent is strongly preferred, or a minimum of 2 years of Validation experience.

Employment at Bryllan (Biovire) is contingent upon a successful Background check.

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Validation Specialist • Brighton, MI, US

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