Validation Supervisor (Canton, MA)

Organogenesis Inc.; Canton (MA); On-site; USD 80,000 - 120,000; Full time

Job summary

A leading regenerative medicine company seeks a Validation Supervisor to oversee and support validation activities in Canton, MA. The role involves developing and implementing validation processes for equipment used in the manufacture of their advanced wound care products. Candidates should have a Bachelor's degree and significant experience in the pharmaceutical or medical device industry, with strong supervisory and technical skills.

Benefits

401k with employer match

Comprehensive medical, dental, and vision coverage

Education Assistance Policy

Employee Assistance Program

Generous paid time off

Qualifications

• 7+ years of experience in validating cGMP systems.
• Deep understanding of aseptic processing and clean room operations.
• Validation experience in Pharmaceutical/Medical Device industry required.

Responsibilities

• Develop strategies for validation of facility and equipment.
• Oversee Validation Engineers and ensure timely completion of tasks.
• Maintain requalification schedules for GMP equipment.

Skills

Organizational skills

Technical writing

Supervisory skills

Education

Bachelor's Degree

Tools

Kaye Validator/AVS

Blue Mountain Regulatory Asset Manager

Job description

About Us

We are a leading regenerative medicine company in the advanced and acute wound care space and are always looking for exceptional talent. Join a company where you will have an opportunity to grow professionally and personally and give strength to others byEmpowering Healing.Our advanced wound care products are specially developed for the successful treatment of chronic and acute wounds. Our comprehensive portfolio of skin substitutes and other regenerative medicine products empower our patients with life-changing solutions. Our mission is to advance healing and recovery beyond expectations.

What You Will Achieve:

The Validation Supervisor will be designated to support and supervise validation activities at Canton, MA facilities.In this role, the candidate will be responsible for developing strategies for validation of facility, equipment, utilities for manufacture of OI products. The candidate will develop protocols, and maintain records for installation, operation, performance qualification and requalification/revalidation protocols for manufacturing equipment, clean rooms and utility systems using GMP validation standards and procedures. In addition, the Supervisor will also assist in process and equipment validations. The position has interaction with all other internal departments. The supervisor will be responsible for overseeing the activities of Validation Engineers, including the scheduling, review, and approval of validation protocols and reports.

This position reports to the Associate Director of Validation and is an on-site position at our Canton, MA facility Monday - Friday.

How You Will Achieve It:

• Develops plans and coordinates activities for validation of GMP equipment including autoclaves, glass washers, depyrogenation ovens, utility systems (purified water, WFI water, gas systems, clean steam), incubators, clean rooms, freezers, smoke studies, and cold rooms for products.
• Oversees the activities of the Validation Engineers, including training, project scheduling and timely completion of established tasks.
• Maintains the requalification schedule for GMP equipment. Inputs new equipment into qualified database for tracking of GXP equipment.
• Captures required updates to the Validation Master Plan for the Site.
• Develops and implements standards and procedures to be used in the creation of validation protocols and reports.
• Reviews protocols and reports for validation and revalidation work as necessary
• Review of QC Laboratory equipment validations and other CSV type qualifications.
• Performs testing using standard concepts, practices and procedures of the cGMP process as required
• Assist as a technical resource for process and equipment validations as required.
• Participate in the creation and/or review of Standard Operating Procedures (SOPs) for system projects
• Contribute as the validation representative on cross functional project teams.
• Orders necessary supplies for support of ongoing qualifications.
• Reviews and approves Quality Systems documents such as Change Controls, Deviations, CAPAs where applicable

Requirements

What You Need to Achieve It:

• Bachelor's Degree in relevant discipline required
• 7+ years of experience in validating cGMP systems
• Validation experience in Pharmaceutical/Medical Device industry required
• Deep understanding ofaseptic processing and clean room operations
• Supervisory experience in a GMP environment preferred
• Able to work independently
• Possess strong organizational skills
• Excellentwritten and verbal communication skills including technical writing
• Competency with Kaye Validator/AVS and various datalogger systems programming, validation of test equipment
• Previous experience with BMRAM preferred
• Familiarity with Blue Mountain Regulatory Asset Manager software preferred

What can we offer you?

• 401k -- generous employer match with immediate vesting and financial planning resources
• Comprehensive Medical, Dental and Vision coverage options effective on day one of employment
• Flexible Spending Account (medical expenses or dependent care expenses) or Health Savings Account
• Company paid insurances including Short Term, Long Term and Life insurances as well as voluntary options
• Paid maternity leave and parental leave for all new parents
• Adoption benefits
• Education Assistance Policy – up to $5,000 per year for all employees
• Wellness Program including free trainings on mental health, mindfulness, stress reduction, on-site flu shots and more
• Employee Assistance Program
• Generous paid time off including vacation, floating holidays, sick days, and company holidays
• Free parking including an electric charging station (Canton and La Jolla)
• Discounts at BJs Wholesale, Dell, Sullivan Tire, and Sprint

We are an equal opportunity/affirmative action employer. All qualified applicants will receive consideration for employment without regard to age, sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, genetic information or any other characteristic protected by law.

We do not accept unsolicited agency resumes and we are not responsible for any fees related to unsolicited resumes.