Technical Ops Change Control Specialist (Biologics, GMP, Temp-to-Perm)(v717)

  • Contract Duration: 12+ months, Onsite
  • Manufacturing
  • Boston, MA

Website Lenox Executive Search

Job description

12+ month onsite CONTRACT role with strong potential to extend and/or convert to Permanent. Must have 5+ years Change Control experience in a GMP environment.

Lenox Executive Search is seeking an experienced Technical Operations Change Control Specialist to fill a Temp-to-Perm role with a global pharmaceutical company in Boston, MA. Must have experience writing change controls for biotech (biologics preferred) in an electronic Quality Management System such as Veeva or Trackwise.

REQUIREMENTS for the Technical Operations Change Control Specialist:

  • 5+ years in a GMP environment in biotech/pharmaceuticals. Preferably as a manufacturing specialist, process engineering, or QA specialist
  • Experience writing change controls for biotech (biologics preferred) in an electronic Quality Management System such as Veeva or Trackwise. Write change controls and follow up with next steps
  • Needs to have GMP manufacturing experience, not just R&D – upstream and downstream processes
  • Experience with tech transfer process. Understands the different purposes and cGMP requirements for pilot runs, engineering runs, PQ runs etc.
  • Some experience setting up new sites, labs or cleanroom preferred
  • Excellent written skills. Can write clearly and effectively without requiring major corrections or oversight (no grammatical errors). Ability to convey complex processes in straightforward language
  • Ability to read and interpret complex technical documents, such as experimental protocols and reports,manufacturing batch records, and regulatory filings
  • Strong sense of ownership. Role requires following up with stakeholders to ensure assessments and tasks have been completed.
  • Problem solving and conflict resolution skills. Experience removing roadblocks, facilitating solutions and driving alignment.
  • Reviewing documents going to for regulatory filings
  • Act as Mini project manager

RESPONSIBILITIES of the Technical Operations Change Control Specialist:

  • Initiate the change control process. Gather information from the requesting department, bring information to the change control committee for endorsement, initiate the change control record in eQMS describing the change and the justification, drive the completion of the assessments and the tasks, follow up on task completion, submit required documentation to close out the change control
  • Work with technical SMEs (Regulatory, Engineering and Facilities, Manufacturing Science and Technology, Process Development, Supply Chain, Validation) to ensure the appropriate stakeholders are involved in the assessment of the change control and completion of the tasks
  • Ensure the change controls are written with appropriate detail for review by regulatory agencies
  • Scope of change controls includes but not limited to: Introduction of new process equipment, changes to existing process equipment, technical transfer of new process from Process Development to Manufacturing, tech transfer between manufacturing sites, changes to existing process, scale-ups, changes to Raw Materials, introduction of new programs/strategies,
  • Verify the impact of the change on regulatory filings
  • Negotiate with QA partners and obtain alignment on requirements
  • Develop and manage the timeline for completion of the tasks. Follow up with the task owners to ensure that the change control does not become overdue.
  • Escalate any risks or issues encountered during the execution of the change control

Job Type: Contract

Salary: $65.00 – $75.00 per hour


  • Monday to Friday

Ability to commute/relocate:

  • Boston, MA: Reliably commute or planning to relocate before starting work (Required)

Application Question(s):

  • Are you vaccinated?


  • Change Control in GMP manufacturing: 5 years (Preferred)
  • Tech Transfer Process: 5 years (Preferred)
  • Veeva or Trackwise: 5 years (Preferred)
  • Manufacturing batch records: 5 years (Preferred)
Upload your resume here.

Our COVID-19 Policy

As with other larger employers and customer-facing organizations, Lenox Executive Search is carefully monitoring the situation regarding Coronavirus (COVID-19), with a particular focus on public health guidance offered by the CDC and state officials.  We are reaching out to make you aware of our activities and preparations in light of the spread of the Coronavirus (COVID-19). Our number one priority is the safety of our employees, clients and the broader community. Given the current unpredictable nature of the spread of COVID-19, and in an abundance of caution, Lenox Executive Search has implemented the following practices immediately:
  • We have increased our overnight cleaning activities to ensure frequently touched areas are being disinfected and sanitized.
  • We have implemented social distancing techniques to minimize the typical face-to-face- contact by utilizing teleconference calls and flexible workspaces.  We have suspended non-essential business travel for our employees and have asked that inter-company meetings be conducted via teleconference. In addition, we kindly ask all of our customers to help us maintain a handshake-free zone at all Lenox Executive Search locations.
  • We have asked employers who feel ill to stay home.
  • We have convened a team of senior leaders who meet daily to discuss the situation and stand ready to take additional steps, if necessary.
  • We have measures in place to ensure our operations can effectively continue so that we can provide our clients uninterrupted service.  Lenox Executive Search already had robust and detailed business continuity plans in place.
– The Lenox Executive Search Team