CRISPR Therapeutics

biopharmaceutical

GxPFacilitiesSpecialist

$90–90k Framingham, Massachusetts, United States FULL TIME
Market Sentiment
HIGH DEMAND

Neural analysis suggests this role is
optimal for Mid+ candidates.

The Brief

“GxP Facilities Specialist at CRISPR Therapeutics. Skills: process support equipment and plant utility maintenance, cGMP manufacturing facilities utility systems and process equipment maintenance and repair, troubleshooting, repair, maintenance scheduling software, leadership. day-to-day work of building and utility operations and repair. maintenance program execution”

Industry & Context.

biopharmaceutical
Problems you'll solve

excellent problem-solving ability; Troubleshoot equipment and systems; identify root cause

Eligibility Requirements

Provide “on-call” support on a rotating basis, Support regular 24-7 operation of facility and respond, Must be able to provide 24/7 off hours emergency coverage

What They're Looking For.

Must Have

10+ years of experience performing process support equipment and plant utility maintenance, troubleshooting and repair required, 10+ years of experience working in a cGMP environment is required, Proven ability to effectively lead, influence and course correct as needed, Experience in installation of new equipment and systems, as well as, developing their maintenance SOPs, Experience interfacing with multiple external vendors, Ability to effectively communicate and collaborate with internal and external stakeholders, Ability to work effectively in a collaborative team environment, knowledge, troubleshooting skills and maintenance competence on GMP utilities and equipment, Proficient knowledge of controls and automation, Self-driven, independently motivated, data driven and excellent problem-solving ability, Proficient in use of CMMS and BMS systems, Must be able to provide 24/7 off hours emergency coverage

Nice to Have

Certificate or Associate’s degree in related field, Industrial wastewater license, HVAC/R certification, Trades license, Quality Management Software for CAPA exception initiation experience preferred, Experience with Blue Mountain and/or Alberio systems a plus

What You'll Do.

day-to-day work of building and utility operations and repair

maintenance program execution

GxP manufacturing environment shutdown support and execution

maintenance and repair of cGMP manufacturing facilities utility systems and process equipment

Perform preventative and corrective maintenance activities to support process equipment and systems

Support efforts in developing remediation for follow-up and emergency work

Perform all work using all prescribed safety procedures

Troubleshoot equipment and systems and repair malfunctioning equipment

Work with equipment owners/engineers and direct the performance of work by equipment vendors

Responsible for periodic inspections of equipment to ensure they are operating properly and safely

Assist with installation of equipment and write safety and maintenance procedures for new equipment

Effectively train equipment technicians

Lead troubleshooting activities to identify root cause and take immediate and appropriate action to implement the repair

Work with maintenance scheduling software to initiate

and reconcile maintenance work orders

Respond to alarms and document activities in accordance with cGMP requirements

Develop remediation activities for alarms

Assume a leadership role and effectively communication to Management when deemed necessary

Other duties as required

Provide “on-call” support on a rotating basis

Support regular 24-7 operation of facility and respond

How You'll Work.

Team & Collaboration

Work with equipment owners/engineers; Ability to effectively communicate and collaborate with internal and external stakeholders; Ability to work effectively in a collaborative team environment; Assume a leadership role and effectively communication to Management when deemed necessary

Communication Scope

Ability to effectively communicate and collaborate with internal and external stakeholders; effectively communication to Management

Process & Methodology

maintenance program execution, maintenance scheduling software to initiate, execute, and reconcile maintenance work orders

Full Job Description

_**Job Description:**_ **Company Overview** Founded over a decade ago, CRISPR Therapeutics is a leading biopharmaceutical company focused on developing transformative gene-based medicines for serious human diseases. The Company has evolved from a pioneering research-stage organization into an industry leader, marking a historic milestone with the approval of CASGEVY® (exagamglogene autotemcel [exa-cel]), the world’s first CRISPR-based therapy, approved for eligible patients with sickle cell disease and transfusion-dependent beta thalassemia. CRISPR Therapeutics is advancing a broad and diversified pipeline across hemoglobinopathies, cardiovascular, autoimmune, oncology, regenerative medicine and rare diseases. The Company continues to expand its leadership in gene editing through the development of SyNTase™ editing, a novel and proprietary gene-editing platform designed to enable precise, efficient, and scalable gene correction. To accelerate and expand its impact, CRISPR Therapeutics has established strategic collaborations with leading biopharmaceutical partners, including Vertex Pharmaceuticals. CRISPR Therapeutics AG is headquartered in Zug, Switzerland, with its wholly-owned U.S. subsidiary, CRISPR Therapeutics, Inc., and R&D operations based in Boston, Massachusetts and San Francisco, California. **Position Summary** The role will be responsible for the day-to-day work of building and utility operations and repair, maintenance program execution, technician training and emergency response. Prior experience in GxP manufacturing environment shutdown support and execution, maintenance and repair of cGMP manufacturing facilities utility systems and process equipment. **Responsibilities** * Perform preventative and corrective maintenance activities to support process equipment and systems, in accordance with established procedures and/or approved practices. Support efforts in developing remediation for follow-up and emergency work. * Responsible for performing all w

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