Sr. Validation Engineer

This position resides in a department whose responsibility is the commissioning / qualification of facilities, utilities and equipment and the validation of manufacturing, packaging and cleaning / sanitization processes used in the production of OTC drugs and cosmetics and pharmaceuticals.

• Duties & Responsibilities:
• Train on Site Validation Master Plans. Maintain Site Validation Master Plans to reflect evolving regulatory and corporate requirements.
• Train on Validation Department and related SOPs. Maintain an on-time training record of 95+%. Maintain Validation Department SOPs. Provide Department SOP training on an as-needed basis.
• Create and maintain Commissioning / Qualification / Validation (C/Q/V) protocol and report templates.
• Serve as Core Team / Extended Team member to FPX Project Teams. Provide design review of equipment / processes. Provide C/Q/V strategy to Project Team. Track project validation schedule. Provide project deliverables via FPX Project Team / Core Team Member. Prepare quotations for validation services and forward to Project Manager. Draft Capital Authorization Requests for validation resources and track through the approval process.
• Develop C/Q/V protocols from their reference documentation and administer their approval. Execute protocols. Perform any sampling / testing / inspection required. Compile results. Perform statistical analysis as required by the protocol. Identify and resolve deviations, with input from Project Team. Issue interim and final reports. Coordinate resources / schedule as required.
• * Develop cleaning / sanitization methodology and criteria.

*

• Draft / review / approve site cleaning SOPs. Train Operations on cleaning SOPs on an as-needed basis.

• Provide SME input to Site Change Control Committee. Revalidate as required.
• Interact with auditors on an as-needed basis. Provide response to audit observations. Define, manage and execute projects designed to remediate audit observations.
• Subscribe to the JNJ Safety Culture by maintaining a 100% training quotient and demonstrated safe behavior.
• Qualifications
• Education: BS degree in Engineering or other appropriate technical discipline is required. Continuing education in pharmaceutical technology and / or cGMP is preferred.
• Experience: Ten (10) plus years of related experience in Validation / Quality / Engineering in an FDA/cGMP compliant manufacturing environment is required.

• Knowledge, Skills and Abilities:
• Excellent interpersonal and communication skills, both verbal and written, are required. Special emphases on technical writing, requiring no edits.
• Proven track record of meeting project objectives required. Successfully planning, tracking and executing validation projects with respect to scope, quality, time and cost.
• Ability to manage multiple conflicting priorities required.
• Superior engineering aptitude required. Demonstrated ability to cross the validation disciplines (i.e. equipment, automation, manufacturing, packaging, cleaning) with subject matter expertise.
• Expert knowledge of the code of Federal Regulations and cGMPs relating to the field of validation.
• Demonstrate ability to lead. Perform all duties unsupervised.
• Quantify resource requirements in area of responsibility for purposes of capital appropriation. Build culture of proactive quality. Provide ad hoc counsel to department staffers.
• Perform the above-listed Duties and Responsibilities in accordance with all Company policy and Lititz Standard Operating Procedures.

Job Type: Full-time

Pay: $84,000.00 - $125,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Flexible schedule
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Retirement plan
• Tuition reimbursement
• Vision insurance

Schedule:

• 8 hour shift
• Monday to Friday

Supplemental pay types:

• Bonus pay

Ability to commute/relocate:

• Reading, PA 19610: Reliably commute or planning to relocate before starting work (Required)

Experience:

• Manufacturing: 1 year (Preferred)

Work Location: Hybrid remote in Reading, PA 19610

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