Opportunities

JOB DESCRIPTION:

JOB TITLE: Validation Engineer

DEPARTMENT: Quality Assurance

SUPERVISOR: Validation Manager

Description:

Norac Pharma is seeking a highly motivated individual with proven technical ability, strong communication skills, and accomplished problem solving acumen to join us as a Validation Engineer. You will develop and execute scientific tests and experiments for equipment, computerized systems, and cleaning processes to generate data required to prove compliance with regulatory and internal company standards in order to produce quality API products. You will work with cross functional groups to meet validation and metrology requirements and ensure Norac Pharma meets all of its quality and operational requirements. This role will be a dynamic and critical hands-on resource reporting to the Validation Manger.

Responsibilities:

• Responsible and accountable under the guidance of the Validation Manager to perform the validation of computerized systems, equipment, facilities, and cleaning processes.
• Utilize measuring equipment and computerized systems in the field to perform the execution of validation protocols, re-qualifications, calibrations, and preventative maintenance.
• Administer the Norac Pharma Work Order system. Review and approve completed work orders, PMs, temperature mappings, and calibrations.
• Develop and deliver a complete package of validation documents and system-specific SOPs using GAMP methodology including: User, Functional and Design Specifications, Validation Project Plans (VPP), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Computerized Systems Validation (CSV), Final and Technical Reports, Risk Assessments and Failure Mode Effects Analysis (FMEA), Change Management Test Protocols, Administration and User SOPs, Work Instruction (WIs), and Forms.
• Responsible for face to face interface and coordination with QC and Manufacturing to execute qualifications for laboratory instruments, equipment, computerized systems, and cleaning validation.
• Maintain cGMP computerized system requirements and Quality Assurance computerized systems databases to meet all regulatory requirements and ensure efficient user workflows. Develop and assist in the configuration of new Quality Assurance computerized systems and qualify enhanced functionality and upgrades.
• Responsible for implementing cGMP quality requirements for computerized systems throughout the organization. Define, implement, configure, maintain, and qualify computerized systems and applications as assigned by the Validation Manager. Perform computerized system risk assessment. Develop cGMP computerized systems testing protocols, execute test scripts, and communicate project progress to Validation Manager throughout the computerized systems validation lifecycle.
• Qualify cleaning processes to meet all regulatory requirements and ensure efficient API manufacturing. Assist in establishing, maintaining, and monitoring cleaning processes.

• Execute validation responsibilities and projects assigned by Validation manager.
• Perform and plan validation and calibration tests assigned based upon project and manufacturing schedules.
• Identify and resolve non-conformances/deviations. Perform investigations and implement corrective actions related to CAPAs.
• Integrate vendor generated and/or performed qualifications into an overall equipment qualification that meets Norac Pharma cGMP requirements.
• Develop, maintain, and administer changes to cGMP computerized systems including revision of specifications, risk assessments, and system operating procedures.
• Determine customer requirements to develop hardware and software specifications.
• Analyze and configure cGMP computerized systems including: concept, design, fabrication, test, installation, operation, data integrity, maintenance, and decommissioning.
• Guide the identification of risks and the development of mitigation strategies for cGMP systems through risk assessment.
• Ensure the logical and systematic conversion of Norac Pharma requirements into qualified system solutions that acknowledge technical, schedule, and cost constraints.
• Provide technical support and perform training throughout Norac Pharma for cGMP Computerized Systems.
• Perform validation assessments and execute qualification test plans on changes to equipment and computerized systems.
• Other duties as assigned.

Education / Experience / Personal Requirements:

• Strong technical writing skills required.
• BA/BS degree in Chemistry, Engineering, Life Sciences or other science degree with 2+ years of validation experience in the biotechnology, pharmaceutical or medical device industry or equivalent.
• Validation experience in a cGMP environment (IQ, OQ, PQ) is essential; specific computerized system validation, equipment qualification, and cleaning validation experience is strongly preferred; additional engineering, laboratory, and validation experience is a plus.
• Demonstrated exposure to a broad range of cGMP Quality Systems such as validation, change control, documentation tracking, analytical testing, and pharmaceutical manufacturing.
• Strong working knowledge and experience in designing test scenarios and test scripts, compiling test results, and creating documentation. Knowledge of FDA requirements for computerized systems, including 21 CFR Part 11, EU GMP Annex 11, and cGMP practices.
• Ability to work at the place of manufacturing/operations/QC including the carrying of test equipment/materials up to 25 lbs and the scaling of ladders. Available for weekend and off shift work as required.
• Well-developed computer skills and fluent with productivity programs and computerized database systems.
• Knowledge and experience with GAMP's approach to validation.
• Strong verbal and written communication skills. Can work well in a team environment to achieve results.
• Recognizes computer software problems, can investigate problems and take appropriate steps to resolve and communicate issues. Recognizes technological limitations and addresses them.
• Ability to understand business and technical requirements. Exhibits sound scientific judgment based on reasonable assumptions and available information.
• Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities. Ability to function efficiently and independently in a changing environment.
• Self-motivated and willing to accept temporary responsibilities outside of initial job description.
• Ability to think critically, and demonstrated troubleshooting and problem solving skills.

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JOB DESCRIPTION:

JOB TITLE: Senior Chemist II Process Research and Development

DEPARTMENT: Process Research and Development

SUPERVISOR:Projects Leader, Projects Leader I, Projects Leader II, Principal Scientist, Senior Principal Scientist, Group Leader, Senior Group Leader, Associate R&D Director or Director, Process Research and Development

Description:

The Process Research and Development Senior Chemist II provides technical leadership to perform synthetic chemistry experiments developing and validating process chemistry for new and/or established products and projects, characterizing reaction products and intermediates with appropriate methods and maintaining laboratory records in accordance with cGMP/GLP practices and requirements.

Responsibilities:

• Primary Responsibilities:
• Assist in evaluating the feasibility of synthesizing compounds that may be brought to Norac Pharma.
• Develop and validate synthetic lab and pilot plant processes to produce a variety of organic and organometallic compounds.
• Conduct relevant literature searches.
• Develop lab scale procedures for the syntheses of organic compounds.
• Optimize the procedure to improve yields in the syntheses of organic compounds.
• Scale up the lab process to produce pilot plant and production quantities of the compounds in accordance with cGMP requirements.
• Write Development Reports on synthesis and scale up projects per cGMPs.
• Maintain complete laboratory records in accordance with accepted laboratory practices, SOPs, and regulatory requirements.
• Develop analytical methodologies
• Monitor yield and efficiencies of processes after commercial startup at the plant.
• Help establish necessary practices to ensure GLP/cGMP compliance.
• Take on Project Leader responsibilities and manage the work load vs. project timelines to complete projects on time, within budget and achieving the desired quality.
• May provide direct supervision to junior staff as well as work in a mentoring role. Acts as peer review for work of others, consistent with training.
• Assist with the preparation / review of controlled and regulatory documents.
• Work with contract organizations as necessary.
• Adheres to current Good Manufacturing Practices (cGMP’s).
• Verbal interaction with clients to discuss scientific results.
• Safety Responsibilities:
• Actively support the Environmental, Health & Safety programs of Norac Pharma to ensure employee and plant safety and security
• Perform a critical review of the processes to determine potential risk and make recommendations to mitigate the risks.
• Work with management, technical personnel, and EHS director to ensure any new process or changes to existing processes follow OSHA PSM guidelines.
• Ensure compliance with OSHA and other safety regulations (e.g., hot work, lock out tags, confined work space, etc.).

Education / Experience / Personal Requirements:

• M.Sc. in Chemistry (or equivalent) with 15+ years of work experience in the synthesis and manufacture of active pharmaceutical ingredients
• Ph.D. in Chemistry (or equivalent) with 5+ years of work experience in the synthesis and manufacture of active pharmaceutical ingredients
• Hands on experience with a variety of analytical equipment such as HPLCs, GCs, and usual organic spectroscopic instrumentation.
• Displays excellent working knowledge of cGMP/GLP principles and able to apply the principles.
• Excellent interpersonal and leadership skills.
• Ability to operate in a decentralized environment.
• Ability to manage multiple tasks and prioritize work.
• Self-motivated with strong organizational and time management skills.
• Demonstration of previous managerial experience and/or team leading experience is preferred.
• Ability to work as part of a multi-disciplinary team and coordinate activities with cross-functional departments.

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