Job description

The Director of Validation is responsible for leading all Installation and Operation Qualifications for equipment and electronic systems, as well as all Process Qualification and Process Validation activity. This role is responsible for the effective and compliant management of the policies, procedures and programs specific to the qualification and validation of BioSpectra equipment and processes for all BioSpectra products. This position is responsible for ensuring that all processes and systems are maintained in a state of validation according to cGMPs.

Essential Duties and Responsibilities:

• Leads the equipment and process qualification/validation lifecycle program for all current and new products or processes at each BioSpectra facility.
• Responsible for the continued success of product launch through completion.
• Builds qualification and validation plans based on the risk assessments, process design and the capabilities defined for utilities and equipment.
• Ensures processes remain in a state of validation and qualification by programs and staff through leading continuous process verification.
• Ensures the successful execution of validation and qualification plans to establish processes that consistently produce products meeting predefined specifications within approved parameters.
• Ensures automated systems are validated in accordance with current good manufacturing practices and data integrity standards.
• Builds the procedures and policies necessary for the successful transition of products from development to commercial manufacturing including interpretation of scale-up activities and technology transfer reports.
• Builds the program for effective validation and qualification reports for cGMP equipment qualifications.
• Evaluates, implements, and documents implementation plans for approved changes for process, equipment and systems.
• Other duties may be assigned by the President of the BioSpectra.

Qualifications:

• Bachelor of Science degree in Science related field or equivalent experience and a minimum of ten years related experience in process technology or validation and qualification.
• Understanding of process development, process validation, equipment qualification, and cGMP.
• Knowledge of the requirements of applicable regulatory and industry standards.
• Ability to effectively present information to Senior management and other groups.
• Strong verbal and written communication skills.
• Strong interpersonal skills with the ability to build and maintain strong working relationships.
• Strong leadership and supervisory skills.
• Strong analytical and problem-solving skills.

Physical Requirements:

• Lift up to 20 lbs. occasionally
• Prolonged periods sitting at a desk and working on a computer
• Ability to see and distinguish color
• Bend, stoop, and carry
• Repeating motion that may include wrists, hands, and fingers

Work Hours & Schedule:

The Director of Validation will be required to work a minimum of 45-50 hours per week and is a salaried position. Extenuating circumstances may require additional time for certain periods. It is widely assumed that displacement of hours and/or days will occur on recurring and non-patterned bases. This job function may include travel. This BioSpectra function may require the ability and willingness to travel to the Bangor, PA, Stroudsburg, PA, Wind Gap, PA or Rensselaer, NY Facilities.

Job Type: Full-time

Pay: From $110,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Flexible schedule
• Health insurance
• Life insurance
• Paid time off
• Parental leave
• Referral program
• Vision insurance

Schedule:

• 10 hour shift
• 12 hour shift
• Monday to Friday

Supplemental pay types:

• Bonus pay

Ability to commute/relocate:

• Bangor, PA 18013: Reliably commute or planning to relocate before starting work (Required)

Experience:

• Manufacturing: 1 year (Preferred)

Shift availability:

• Day Shift (Preferred)

Work Location: One location

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